Some of the issues cited:
- The "firm’s laboratory tested a sample of finished dog food kibble, Evolve Chicken and Rice Dog Formula (b)(4), and detected an elevated aflatoxin level of 32.7 ppb. This is an indication that [the company] failed to implement your ingredient testing preventive control Despite this, [the company] did not hold the out-of-specification dog food for determination of disposition, as required by [the] corrective actions in [the] food safety plan and SOPs. [The plan states] that any product that is determined to fall outside of [the] specifications should be placed on hold."
- The "firm failed to implement your preventive control when [the company] failed to follow the manufacturer’s mycotoxin test kit instructions, as well as [the] firm’s (b)(4) regarding sample preparation for incoming grain analysis."
- "The Minnesota Department of Agriculture collected a routine surveillance sample of [the comany's] pet food “Sprout Sporting Dog Food” from retail and laboratory analysis detected Salmonella Johannesburg in the sample, resulting in a Class I recall described above."
- FDA inspection, investigators collected environmental swabs. Salmonella spp. was found on a compressed air nozzle, including the hose and reel, located in [the] post lethal treatment shaker screen room between Shaker Screen D and Shaker Screen E. {The] firm utilizes compressed air nozzles to blow off floors and equipment. FDA investigators observed at least two employees who were using compressed air to remove adhered food debris on equipment cause a nozzle to come in direct contact with food contact surfaces by scraping the surfaces with the nozzle."
https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/sunshine-mills-inc-618141-03072022
WARNING LETTER
Sunshine Mills, Inc
MARCS-CMS 618141 — MARCH 07, 2022
Recipient:
Mr. Alan Bostick
CEO
Sunshine Mills, Inc
500 6th St. SW
Red Bay, AL 35582
United States
Issuing Office:
Human and Animal Food East V Compliance Branch (HAFE5-CB)
United States
Dear Mr. Bostick:
The U.S. Food and Drug Administration (FDA) inspected your pet food manufacturing facility located at 2103 South Gloster Street, Tupelo, MS for 15 days between July 19 and September 1, 2021. This inspection was conducted as a follow up to a regulatory meeting we held with you, members of your management team, and your general counsel on March 26, 2021.
Our inspection found evidence of significant violations of the Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Food for Animals regulation, Title 21, Code of Federal Regulations, Part 507 (21 CFR Part 507). Failure of the owner, operator, or agent in charge of a covered facility to comply with the preventive control provisions of 21 CFR Part 507 (located in subparts A, C, D, E, and F of Part 507) is prohibited by section 301(uu) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) [21 U.S.C. § 331(uu)]. Additionally, the criteria and definitions in 21 CFR Part 507 apply in determining whether an animal food is adulterated within the meaning of section 402(a)(4) of the FD&C Act [21 U.S.C. § 342(a)(4)] in that it has been prepared, packed, or held under insanitary conditions whereby it may have been rendered injurious to health (see 21 CFR 507.1(a)(1)(ii)). The introduction or delivery for introduction into interstate commerce of an adulterated food is prohibited under section 301(a) of the FD&C Act [21 U.S.C. § 331(a)].
You may find the FD&C Act and FDA’s regulations through links on FDA’s homepage at www.fda.gov.
We must note, from August 24, 2020 – July 29, 2021, your firm has conducted five recalls of products manufactured at your Tupelo plant:
• Class I - On August 24, 2020, you recalled finished dog food that had been tested by the Georgia Department of Agriculture and found to contain Salmonella.
• Class I - On September 2, 2020, you recalled finished dog food that was tested by the Louisiana Department of Agriculture and found to contain aflatoxin at a level of 82.4 parts per billion (ppb).
• Class I - On October 7, 2020, during an FDA inspection of your firm, the inspection revealed you accepted a load of corn which tested at 76.1 ppb for aflatoxin on April 3, 2020, and which was used to manufacture pet food. On October 8, 2020, your firm expanded the September 2, 2020, recall to included additional affected products.
• Class I - On June 2, 2021, your firm recalled finished dog food after the Minnesota Department of Agriculture sampled dog food and found Salmonella Johannesburg.
• Class II - On July 23, 2021, during our inspection, FDA discovered your firm introduced into interstate commerce finished dog food which tested at 32.7 ppb for aflatoxin. On July 29, 2021, your firm recalled the affected products.
Meeting Request
We would like to meet with you to discuss the inspectional findings, your current food safety plan, the contents of this letter, and to ascertain how you will ensure your corrective actions are sustainable and prevent any violation of the FD&C Act. A meeting is scheduled for April 4, 2022, at 11:30 a.m. CST. The meeting will be held via teleconference. Please contact Compliance Officer Allison Hunter by phone at (513) 322-0629 or via email at Allison.Hunter@fda.hhs.gov on or before March 18, 2022, to confirm this meeting and to provide a list of attendees. Once you have confirmed attendance, the dial-in information will be provided.
After the March 2021 regulatory meeting but before the current inspection, we sent you a letter, dated July 15, 2021. At the close of the inspection, you were issued a Form FDA 483, Inspectional Observations. We acknowledge your written responses dated August 9, 2021, September 23, 2021, and October 21, 2021, explaining what you have done or plan to do to address our concerns. We have reviewed your responses and we address your corrective actions below.
Hazard Analysis and Risk-Based Preventive Controls Requirements
Your animal food facility is subject to the hazard analysis and risk-based preventive controls requirements found in 21 CFR Part 507, subparts A, C, D, E, and F. During the inspection of your facility, the FDA Investigator noted evidence of violation of these requirements, as follows:
1. You failed to identify and implement preventive controls to provide assurances that any hazards requiring a preventive control will be significantly minimized or prevented and the animal food manufactured, processed, packed, or held by your facility will not be adulterated under section 402 of the FD&C Act, as required by 21 CFR 507.34(a)(1).
Mycotoxins in Grain/Grain Meals
Your written food safety plan hazard analysis preventive controls summary determines that mycotoxins in ingredients, including bulk grains and grain meals, is a hazard requiring a preventive control. Your preventive control is to test every incoming load of the noted bulk ingredients for the mycotoxins of aflatoxin, vomitoxin (DON), zearalenone, fumonisin, and ochratoxin, in accordance with your Standard Operating Procedure (b)(4). Your food safety plan calls for any incoming ingredients testing out-of-specification to be rejected. Ingredients containing elevated levels of mycotoxin(s) can result in elevated levels of mycotoxins in the finished pet food. On February 12, 2021, your firm’s laboratory tested a sample of finished dog food kibble, Evolve Chicken and Rice Dog Formula (b)(4), and detected an elevated aflatoxin level of 32.7 ppb. This is an indication that you failed to implement your ingredient testing preventive control, resulting in the use of an ingredient containing elevated levels of aflatoxin.
Mr. Alan Bostick
CEO
Sunshine Mills, Inc
500 6th St. SW
Red Bay, AL 35582
United States
Issuing Office:
Human and Animal Food East V Compliance Branch (HAFE5-CB)
United States
Dear Mr. Bostick:
The U.S. Food and Drug Administration (FDA) inspected your pet food manufacturing facility located at 2103 South Gloster Street, Tupelo, MS for 15 days between July 19 and September 1, 2021. This inspection was conducted as a follow up to a regulatory meeting we held with you, members of your management team, and your general counsel on March 26, 2021.
Our inspection found evidence of significant violations of the Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Food for Animals regulation, Title 21, Code of Federal Regulations, Part 507 (21 CFR Part 507). Failure of the owner, operator, or agent in charge of a covered facility to comply with the preventive control provisions of 21 CFR Part 507 (located in subparts A, C, D, E, and F of Part 507) is prohibited by section 301(uu) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) [21 U.S.C. § 331(uu)]. Additionally, the criteria and definitions in 21 CFR Part 507 apply in determining whether an animal food is adulterated within the meaning of section 402(a)(4) of the FD&C Act [21 U.S.C. § 342(a)(4)] in that it has been prepared, packed, or held under insanitary conditions whereby it may have been rendered injurious to health (see 21 CFR 507.1(a)(1)(ii)). The introduction or delivery for introduction into interstate commerce of an adulterated food is prohibited under section 301(a) of the FD&C Act [21 U.S.C. § 331(a)].
You may find the FD&C Act and FDA’s regulations through links on FDA’s homepage at www.fda.gov.
We must note, from August 24, 2020 – July 29, 2021, your firm has conducted five recalls of products manufactured at your Tupelo plant:
• Class I - On August 24, 2020, you recalled finished dog food that had been tested by the Georgia Department of Agriculture and found to contain Salmonella.
• Class I - On September 2, 2020, you recalled finished dog food that was tested by the Louisiana Department of Agriculture and found to contain aflatoxin at a level of 82.4 parts per billion (ppb).
• Class I - On October 7, 2020, during an FDA inspection of your firm, the inspection revealed you accepted a load of corn which tested at 76.1 ppb for aflatoxin on April 3, 2020, and which was used to manufacture pet food. On October 8, 2020, your firm expanded the September 2, 2020, recall to included additional affected products.
• Class I - On June 2, 2021, your firm recalled finished dog food after the Minnesota Department of Agriculture sampled dog food and found Salmonella Johannesburg.
• Class II - On July 23, 2021, during our inspection, FDA discovered your firm introduced into interstate commerce finished dog food which tested at 32.7 ppb for aflatoxin. On July 29, 2021, your firm recalled the affected products.
Meeting Request
We would like to meet with you to discuss the inspectional findings, your current food safety plan, the contents of this letter, and to ascertain how you will ensure your corrective actions are sustainable and prevent any violation of the FD&C Act. A meeting is scheduled for April 4, 2022, at 11:30 a.m. CST. The meeting will be held via teleconference. Please contact Compliance Officer Allison Hunter by phone at (513) 322-0629 or via email at Allison.Hunter@fda.hhs.gov on or before March 18, 2022, to confirm this meeting and to provide a list of attendees. Once you have confirmed attendance, the dial-in information will be provided.
After the March 2021 regulatory meeting but before the current inspection, we sent you a letter, dated July 15, 2021. At the close of the inspection, you were issued a Form FDA 483, Inspectional Observations. We acknowledge your written responses dated August 9, 2021, September 23, 2021, and October 21, 2021, explaining what you have done or plan to do to address our concerns. We have reviewed your responses and we address your corrective actions below.
Hazard Analysis and Risk-Based Preventive Controls Requirements
Your animal food facility is subject to the hazard analysis and risk-based preventive controls requirements found in 21 CFR Part 507, subparts A, C, D, E, and F. During the inspection of your facility, the FDA Investigator noted evidence of violation of these requirements, as follows:
1. You failed to identify and implement preventive controls to provide assurances that any hazards requiring a preventive control will be significantly minimized or prevented and the animal food manufactured, processed, packed, or held by your facility will not be adulterated under section 402 of the FD&C Act, as required by 21 CFR 507.34(a)(1).
Mycotoxins in Grain/Grain Meals
Your written food safety plan hazard analysis preventive controls summary determines that mycotoxins in ingredients, including bulk grains and grain meals, is a hazard requiring a preventive control. Your preventive control is to test every incoming load of the noted bulk ingredients for the mycotoxins of aflatoxin, vomitoxin (DON), zearalenone, fumonisin, and ochratoxin, in accordance with your Standard Operating Procedure (b)(4). Your food safety plan calls for any incoming ingredients testing out-of-specification to be rejected. Ingredients containing elevated levels of mycotoxin(s) can result in elevated levels of mycotoxins in the finished pet food. On February 12, 2021, your firm’s laboratory tested a sample of finished dog food kibble, Evolve Chicken and Rice Dog Formula (b)(4), and detected an elevated aflatoxin level of 32.7 ppb. This is an indication that you failed to implement your ingredient testing preventive control, resulting in the use of an ingredient containing elevated levels of aflatoxin.
Furthermore, your firm failed to implement your preventive control when you failed to follow the manufacturer’s mycotoxin test kit instructions, as well as your firm’s (b)(4) regarding sample preparation for incoming grain analysis. Both the manufacturer’s test kit and your SOPs require passing ground grain samples through a (b)(4) and obtaining a pass-through percentage of (b)(4) for aflatoxin and fumonisin and (b)(4) for DON in order to obtain accurate results. Our investigators observed your laboratory technicians collect a sample of incoming bulk brewers’ rice and run aflatoxin, fumonisin, and DON analysis without first sieving ground grains as required prior to testing. Additionally, the manufacturer’s mycotoxin test kits, used by your firm for detecting aflatoxin, DON, and fumonisin levels, as well as your (b)(4)” require an assessment of the pH and an adjustment, when necessary, in order to obtain accurate results for mycotoxin levels. The inspection revealed your laboratory technicians were not assessing or adjusting the pH on any mycotoxin test conducted on incoming grain and grain by-products. These failures to fully implement your ingredient testing preventive control can cause inaccurate test results, so that your firm accepts incoming ingredients that contain elevated levels of mycotoxins.
Salmonella Recontamination
Your written food safety plan hazard analysis preventive control summary sheet determines that environmental Salmonella post kill step is a hazard requiring a sanitation preventive control. According to your summary sheet, you rely on cleaning and sanitizing post kill step surfaces to significantly minimize or prevent the hazard. Following our March 26, 2021, regulatory meeting, the implementation of your sanitation preventive control continues to be ineffective as evidenced by the following:
A. On May 20, 2021, the Minnesota Department of Agriculture collected a routine surveillance sample of your pet food “Sprout Sporting Dog Food” from retail and laboratory analysis detected Salmonella Johannesburg in the sample, resulting in a Class I recall described above.
B. On August 9, 2021, during the current FDA inspection, investigators collected environmental swabs. Salmonella spp. was found on a compressed air nozzle, including the hose and reel, located in your post lethal treatment shaker screen room between Shaker Screen D and Shaker Screen E. Your firm utilizes compressed air nozzles to blow off floors and equipment. FDA investigators observed at least two employees who were using compressed air to remove adhered food debris on equipment cause a nozzle to come in direct contact with food contact surfaces by scraping the surfaces with the nozzle.
General evaluation of your responses and corrective actions:
We acknowledge your voluntary recalls to remove adulterated product from the marketplace. However, recalling product does not prevent the reoccurrence of a hazard in your pet food. Recalling product is a reaction to an animal food safety system failure that has occurred. It is your responsibility to implement a robust hazard analysis and risk-based preventive controls program to prevent product adulterated with mycotoxin or Salmonella from entering the food supply.
You were previously notified, in a warning letter FDA issued to you on June 25, 2019, of the importance of preventive controls, when your firm attempted and failed to manage the hazard of excess vitamin D in your dog food, which resulted in several dogs developing vitamin D toxicity and a subsequent recall. We also discussed the importance of properly implementing preventive controls to significantly minimize or prevent hazards in your products during the regulatory meeting we held with your firm on March 26, 2021. This regulatory meeting was held, in part, as the result of three Class I recalls of your products due to failure to control the hazards of Salmonella and excessive aflatoxin.
Below, we discuss specific points regarding your mycotoxin and Salmonella responses and corrective actions, as described in your responses dated September 23, August 9, and October 21, 2021.
Evaluation of your Mycotoxin response:
In your responses, you stated the technician and Quality Assurance Supervisor/ PCQI involved in the February 12, 2021, incident is no longer with Sunshine Mills. You provided revised (b)(4) along with training documentation for each SOP. Additionally, you provided a copy of the “(b)(4) PowerPoint presentations and employee training logs. Updates to your (b)(4) include a corporate PCQI review and verification of toxin test results; installing and using (b)(4) software; and implementing an external mycotoxin auditing program.
We will verify the implementation and sustainability of your corrective actions during an inspection of your firm at a later date.
Evaluation of your Salmonella response:
Your responses dated September 23, 2021, and October 21, 2021, failed to address how you will make corrections to your implementation of your sanitation preventive control for Salmonella; therefore, we are unable to evaluate the adequacy of your response.
Furthermore, in your response, you provided your revised (b)(4),” implementation date November 1, 2021, which includes Salmonella as an environmental monitoring testing parameter for your swabbing practices. You also stated you would incorporate actions to follow in the case of a presumptive positive result for Salmonella; however, it appears your Corrective Actions section of the SOP only addresses results for Enterobacteriaceae and/or Total Plate Count that exceed your defined limits with no mention of corrective actions in the case of a Salmonella positive. These corrections relate to environmental monitoring, which is a verification of the effectiveness of implementation of your sanitation preventive control for Salmonella and not the preventive control for the hazard.
2. You did not implement appropriate written corrective action procedures for preventive controls, including procedures to address the presence of a pathogen in animal food detected as a result of product testing, as required by 21 CFR 507.42(a)(1)(i).
Specifically, on February 12, 2021, your firm’s laboratory tested a sample of your finished dog food, Evolve Chicken and Rice Dog Formula (b)(4), and detected an aflatoxin level of 32.7 ppb. Despite this, you did not hold the out-of-specification dog food for determination of disposition, as required by your corrective actions in your food safety plan and SOPs. Your (b)(4),” states your aflatoxin limit on finished product as being (b)(4) and that any product that is determined to fall outside of your specifications should be placed on hold. Your (b)(4),” states all non-conforming products placed on hold will be reviewed and dispositions determined by the Quality Manager and/or Chief Operations Officer and/or VP of Quality and Food Safety. Instead, the February 12, 2021, aflatoxin test result was signed-off as approved by your lab technician, and subsequently by your firm’s Preventive Controls Qualified Individual (PCQI) during secondary verification. The Evolve dog food product was distributed into interstate commerce resulting in the above-mentioned Class II recall.
Evaluation of your response:
Your response dated October 21, 2021, stated you will implement an External Mycotoxin Auditing Program which will include an audit by the PCQI from a sister location or corporate headquarters on a quarterly basis. Your response does not explain how you will fully implement your corrective actions in accordance with 21 CFR 507.42(a). Therefore, we are unable to evaluate the adequacy of your response.
3. Your written corrective action procedures do not describe the steps to be taken to ensure that all affected animal food is evaluated for safety and prevented from entering into commerce if you cannot ensure the affected animal food is not adulterated, as required by 21 CFR 507.42(a)(2)(iii) and (iv).
(b)(4)” documents your firm’s environmental monitoring program microbial swabbing procedures and corrective action procedures in the event an indicator organism is detected. However, (b)(4) does not require you to evaluate affected product after receiving the initial positive swab or include steps to prevent the affected product from entering into commerce. For example, on June 2, 2021, you swabbed and obtained out-of-limit indicator results for Enterobacteria and coliforms on the post lethal treatment direct food-contact surface identified as “E-Line Spout Inside (Right).” Affected finished pet food kibble was manufactured on June 1, 2021, which included ELM PET FOODS brand Salmon Recipe Cat Food Formula (b)(4), Lot: TE1 01 JUNE 2021 in 7 lb. bags. This lot was distributed in interstate commerce without being assessed for food safety.
Evaluation of your response:
In your response dated October 21, 2021, you provided an updated copy of your (b)(4),” which states you will collect environmental swabs weekly and outlines corrective actions should you receive a positive result. Your SOP is not adequate because it still does not require you to evaluate affected product after receiving the initial positive swab. Additionally, if you receive a second positive, your product evaluation does not extend to product produced since the last negative test result; therefore, you are not evaluating all product that could be affected for safety.
Current Good Manufacturing Practice (CGMP) Requirements
Your animal food facility is also subject to the CGMP requirements found in 21 CFR Part 507, subparts A, B, D and F. During the inspection of your facility, FDA investigators noted evidence of violation of these requirements, as follows:
4. You failed to maintain animal food contact surfaces to protect animal food from being contaminated, as required by 21 CFR 507.22(a)(4)(iii).
Specifically,
A) During production on July 20, 2021, FDA investigators observed rubber belt material on Shaker Screens A-E which appeared to be porous and showed evidence of fraying and pitting. These areas are post lethal treatment direct food contact surfaces.
B) During production on July 23, 2021, and August 18, 2021, FDA investigators observed rust and corrosion on your aluminum scale buckets on Scale Line A and Scale Line B. These areas are post lethal treatment direct food contact surfaces.
C) During production on July 23, 2021, FDA investigators observed rust and pitting on the shaker cylinder located inside Shaker Screen A. This area is a post lethal treatment direct food contact surface.
Evaluation of your response:
Your responses dated September 23, 2021, and October 21, 2021, state:
A) The identified rubber belting material has been replaced with a non-porous material on Shaker A-E and you provided documentation of retraining of your sanitation team.
B) You have provided training to your employees on how to identify oxidation on equipment. You ordered replacement scale buckets and will work with your sanitation supply company to assess possible causes of oxidation, work towards mitigation, and develop and implement a preventive maintenance program to visually inspect post lethal treatment direct food contact surfaces for oxidation.
C) You have provided training to employees on how to look for rust, pitting, and oxidation on direct food contact pieces of equipment and you replaced the shaker cylinders with stainless steel housing.
We will verify the implementation and sustainability of your corrective actions during an inspection of your firm at a later date.
5. You failed to keep your plant clean and in good repair to prevent animal food from becoming adulterated, as required by 21 CFR 507.19(a).
During our inspection, FDA investigators observed evidence of roof leaks throughout your post-lethal treatment pet food processing areas during production and dripping onto the floor in high foot traffic areas. FDA investigators also observed rainwater running down food processing equipment during production. Specifically:
A) On July 19, 2021, apparent water droplets were observed dripping from the roof and forming a standing water puddle on the floor in the northwest corner of your packaging area approximately three feet from your E Line Packaging Equipment.
B) On July 20, 2021, apparent water droplets, dripping continuously, were observed leaking from the roof directly into a pool of standing water approximately three feet in front of your #1 Greaser equipment, which is in a post lethal treatment area of your pet food processing facility. Employees were also observed walking in this standing water puddle.
C) On July 21, 2021, and July 22, 2021, apparent water droplets were observed leaking continuously from your drop ceiling directly onto the floor of your primary employee entry and exit door to your pet food processing area. Employees were also observed walking in this standing water upon entry and exit from your pet food processing areas.
D) On July 22, 2021, water was observed dripping from the roof and forming a standing water puddle directly on the floor in the center of the employee designated walkway between the expansion room and the finished product packaging room. Employees were observed walking on this pathway through the standing water.
E) On July 22, 2021, water was observed seeping from the floor of the greaser leg basement room. The pool of standing water was also observed serving as a harborage area for approximately 40 apparent live fly insects. A water hose used for cleaning floors, walls, and post lethal treatment pet food equipment exteriors was also observed making direct contact with the floor approximately ½ -inch from the standing water.
F) On July 19, 2021, apparent water droplets were observed running down the exterior of the #2 Greaser Leg in the expansion room and forming droplets directly across an opening to a post lethal treatment direct food-contact surface.
G) On July 21, 2021, apparent water droplets were observed running down the pet food hopper of your Shaker Screen C machine. The water was observed running down the exterior of the equipment and forming a standing water puddle directly on the floor.
Evaluation of your response:
Your October 21, 2021, response includes a purchase order of a new roof over the extrusion and production area of your plant and photographs showing the roof being replaced. You also stated, “Engineering has determined that a subterranean well will need to be drilled on the outside of the basement walls. This will relieve ground water from entering the basement during excessive rainfalls. Once completed the basement walls will be injected with Dural Aqua-Dam which is a hydrophobic polyurethane grout to seal the basement from its exterior. Projected completion date is estimated to be December 1, 2021.” In addition, the response included a purchase order for supplies to complete this project. We will verify the implementation and sustainability of your corrective actions during an inspection of your firm at a later date.
Conclusion
This letter is not intended to be an all-inclusive statement of violations that may exist at your facility or in connection with your products. You are responsible for investigating and determining the causes of any violations and for preventing their recurrence or the occurrence of other violations. It is your responsibility to ensure that you comply with all requirements of federal law and FDA regulations.
This letter notifies you of our concerns and provides you an opportunity to address them. Failure to adequately address this matter may lead to legal or regulatory action, including without limitation, seizure and injunction.
Furthermore, following the review of your August 9, 2021, September 23, 2021, and October 21, 2021, responses, we have these additional comments:
1. A root cause analysis is part of a common approach to complying with the requirement that appropriate action be taken to reduce the likelihood that a problem will recur (see 21 CFR 507.42(a)(2)(ii)). Knowing the root cause is key to reducing the likelihood that a problem will happen again. To date, your responses do not include documentation showing that you have determined a root cause for the Salmonella contamination that resulted in the Class I recall on August 24, 2020.
2. Your SOP (b)(4),” establishes your limit for DON in ingredients and finished product as 5 ppm. FDA’s “Guidance for Industry and FDA: Advisory Levels for Deoxynivalenol (DON) in Finished Wheat Products for Human Consumption and Grains and Grain By-Products used for Animal Feed” states the advisory level is 5 ppm for DON on grains and grain by-products destined for “all other animals,” which includes dogs and cats, with the added recommendation that these ingredients do not exceed 40% of their diet. Your (b)(4) does not consider the finished product’s formulation when establishing your DON limit in susceptible grains.
3. In our letter to you dated July 15, 2021, we informed you it is not acceptable to use method AOAC 2009.02 (Automated Enumeration of Escherichia coli in Food) for enumeration of Enterobacteriaceae and Coliforms on environmental surfaces because there are methods available specifically for enumeration of Enterobacteriaceae and Coliforms on environmental surfaces: AOAC 2018.05 Enumeration of Enterobacteriaceae in Select Foods and Environmental Surfaces; AOAC 2018.13 Enumeration of Escherichia coli and Coliform in a Broad Range of Foods and Select Environmental Surfaces. We also informed you that environmental hygiene counts should be reported in counts per surface area (e.g., cfu/cm2 or cfu/in2). You responded that Sunshine Mills PNC laboratory is not currently accredited for AOAC 2018.05 and AOAC 2018.13. Until accreditation is achieved, you will not test micro swabs in your internal laboratory. Your revised (b)(4), provided in your October 21, 2021, response, states a third-party laboratory will be used to perform testing for Enterobacteriaceae and Coliforms. However, your SOP still states the method used will be AOAC 2009.02.
It is acceptable for you to use a third-party laboratory for enumeration of Enterobacteriaceae and E. coli/Coliform in environmental swabs. However, as previously stated, AOAC 2009.02 is not an acceptable method. Please provide confirmation that the third-party lab is using and is accredited to run AOAC 2018.05 and/or AOAC 2018.13 and that data will be reported as cfu/cm2 or cfu/in2.
4. In our letter to you dated July 15, 2021, we informed you it is not acceptable to use AOAC 2013.01 for enumeration of Yeast/Mold on environmental surfaces because AOAC 2013.01 is for the detection of Salmonella in a variety of foods and not for enumeration of Yeast/Mold on environmental surfaces. We also informed you that environmental hygiene counts should be reported in counts per surface area (e.g., cfu/cm2 or cfu/in2). You responded that Sunshine Mills PNC laboratory is not accredited for the enumeration of Yeast/Mold on environmental surfaces. Until accreditation is achieved, you will be sending your micro swabs to a third-party testing laboratory with the appropriate testing capabilities.
Your revised (b)(4), provided in your October 21, 2021, response states method AOAC 2009.02 will be used by the third-party laboratory for the enumeration of Yeast/Mold. It is acceptable for you to use a third-party laboratory for enumeration of Yeast/Mold in environmental swabs. However, AOAC 2009.02 is for Automated Enumeration of Escherichia coli in Food and is not an acceptable method for the enumeration of Yeast/Mold. Please provide confirmation the third-party laboratory is using an accredited method for the enumeration of Yeast/Mold in environmental swabs, the lab is accredited to run the method, and the results will be reported as cfu/cm2 or cfu/in2.
5. In our letter dated July 15, 2021, we asked you to provide information on what your ATP baseline levels were and how you derived your acceptable ATP limits. You responded August 9, 2021, that ATP limits were based on the manufacturer’s guidelines as outlined in the manufacturer’s brochures. However, you did not provide documentation to support your RLU limits listed in (b)(4).” Also, please confirm which (b)(4) you use, as the default upper and lower RLU limits of (b)(4) are different from the ones of (b)(4).
Additionally, the reference you provided, “(b)(4),” is for hands and not relevant/applicable for environmental surfaces. This is not an acceptable reference for determining ATP limits for surface testing.
Within fifteen (15) working days of receipt of this letter, please notify this office in writing of the specific steps that you have taken to correct any violations. Include an explanation of each step being taken to prevent the recurrence of violations, as well as copies of related documentation. If you cannot complete corrective actions within fifteen (15) working days, state the reason for the delay and the time frame within which you will complete the correction. If you believe that you have complied with the FD&C Act and FDA regulations, include your reasoning and any supporting information for our consideration. In addition, please be prepared to discuss your reasoning and any supporting information during our upcoming teleconference regulatory meeting.
Please send your firm’s response to Allison C. Hunter, Compliance Officer, U.S. Food and Drug Administration, 550 Main Street, Suite 500, Cincinnati, OH 45202 or via email to ORAHAFEAST5FirmResponses@fda.hhs.gov. If you have questions regarding any issues in this letter, please contact Allison Hunter at 513-322-0629 or via email at Allison.Hunter@fda.hhs.gov.
Sincerely,
/S/
Steven B. Barber
Cincinnati District Director
Office of Human and Animal Food Operations
Division East 5
Salmonella Recontamination
Your written food safety plan hazard analysis preventive control summary sheet determines that environmental Salmonella post kill step is a hazard requiring a sanitation preventive control. According to your summary sheet, you rely on cleaning and sanitizing post kill step surfaces to significantly minimize or prevent the hazard. Following our March 26, 2021, regulatory meeting, the implementation of your sanitation preventive control continues to be ineffective as evidenced by the following:
A. On May 20, 2021, the Minnesota Department of Agriculture collected a routine surveillance sample of your pet food “Sprout Sporting Dog Food” from retail and laboratory analysis detected Salmonella Johannesburg in the sample, resulting in a Class I recall described above.
B. On August 9, 2021, during the current FDA inspection, investigators collected environmental swabs. Salmonella spp. was found on a compressed air nozzle, including the hose and reel, located in your post lethal treatment shaker screen room between Shaker Screen D and Shaker Screen E. Your firm utilizes compressed air nozzles to blow off floors and equipment. FDA investigators observed at least two employees who were using compressed air to remove adhered food debris on equipment cause a nozzle to come in direct contact with food contact surfaces by scraping the surfaces with the nozzle.
General evaluation of your responses and corrective actions:
We acknowledge your voluntary recalls to remove adulterated product from the marketplace. However, recalling product does not prevent the reoccurrence of a hazard in your pet food. Recalling product is a reaction to an animal food safety system failure that has occurred. It is your responsibility to implement a robust hazard analysis and risk-based preventive controls program to prevent product adulterated with mycotoxin or Salmonella from entering the food supply.
You were previously notified, in a warning letter FDA issued to you on June 25, 2019, of the importance of preventive controls, when your firm attempted and failed to manage the hazard of excess vitamin D in your dog food, which resulted in several dogs developing vitamin D toxicity and a subsequent recall. We also discussed the importance of properly implementing preventive controls to significantly minimize or prevent hazards in your products during the regulatory meeting we held with your firm on March 26, 2021. This regulatory meeting was held, in part, as the result of three Class I recalls of your products due to failure to control the hazards of Salmonella and excessive aflatoxin.
Below, we discuss specific points regarding your mycotoxin and Salmonella responses and corrective actions, as described in your responses dated September 23, August 9, and October 21, 2021.
Evaluation of your Mycotoxin response:
In your responses, you stated the technician and Quality Assurance Supervisor/ PCQI involved in the February 12, 2021, incident is no longer with Sunshine Mills. You provided revised (b)(4) along with training documentation for each SOP. Additionally, you provided a copy of the “(b)(4) PowerPoint presentations and employee training logs. Updates to your (b)(4) include a corporate PCQI review and verification of toxin test results; installing and using (b)(4) software; and implementing an external mycotoxin auditing program.
We will verify the implementation and sustainability of your corrective actions during an inspection of your firm at a later date.
Evaluation of your Salmonella response:
Your responses dated September 23, 2021, and October 21, 2021, failed to address how you will make corrections to your implementation of your sanitation preventive control for Salmonella; therefore, we are unable to evaluate the adequacy of your response.
Furthermore, in your response, you provided your revised (b)(4),” implementation date November 1, 2021, which includes Salmonella as an environmental monitoring testing parameter for your swabbing practices. You also stated you would incorporate actions to follow in the case of a presumptive positive result for Salmonella; however, it appears your Corrective Actions section of the SOP only addresses results for Enterobacteriaceae and/or Total Plate Count that exceed your defined limits with no mention of corrective actions in the case of a Salmonella positive. These corrections relate to environmental monitoring, which is a verification of the effectiveness of implementation of your sanitation preventive control for Salmonella and not the preventive control for the hazard.
2. You did not implement appropriate written corrective action procedures for preventive controls, including procedures to address the presence of a pathogen in animal food detected as a result of product testing, as required by 21 CFR 507.42(a)(1)(i).
Specifically, on February 12, 2021, your firm’s laboratory tested a sample of your finished dog food, Evolve Chicken and Rice Dog Formula (b)(4), and detected an aflatoxin level of 32.7 ppb. Despite this, you did not hold the out-of-specification dog food for determination of disposition, as required by your corrective actions in your food safety plan and SOPs. Your (b)(4),” states your aflatoxin limit on finished product as being (b)(4) and that any product that is determined to fall outside of your specifications should be placed on hold. Your (b)(4),” states all non-conforming products placed on hold will be reviewed and dispositions determined by the Quality Manager and/or Chief Operations Officer and/or VP of Quality and Food Safety. Instead, the February 12, 2021, aflatoxin test result was signed-off as approved by your lab technician, and subsequently by your firm’s Preventive Controls Qualified Individual (PCQI) during secondary verification. The Evolve dog food product was distributed into interstate commerce resulting in the above-mentioned Class II recall.
Evaluation of your response:
Your response dated October 21, 2021, stated you will implement an External Mycotoxin Auditing Program which will include an audit by the PCQI from a sister location or corporate headquarters on a quarterly basis. Your response does not explain how you will fully implement your corrective actions in accordance with 21 CFR 507.42(a). Therefore, we are unable to evaluate the adequacy of your response.
3. Your written corrective action procedures do not describe the steps to be taken to ensure that all affected animal food is evaluated for safety and prevented from entering into commerce if you cannot ensure the affected animal food is not adulterated, as required by 21 CFR 507.42(a)(2)(iii) and (iv).
(b)(4)” documents your firm’s environmental monitoring program microbial swabbing procedures and corrective action procedures in the event an indicator organism is detected. However, (b)(4) does not require you to evaluate affected product after receiving the initial positive swab or include steps to prevent the affected product from entering into commerce. For example, on June 2, 2021, you swabbed and obtained out-of-limit indicator results for Enterobacteria and coliforms on the post lethal treatment direct food-contact surface identified as “E-Line Spout Inside (Right).” Affected finished pet food kibble was manufactured on June 1, 2021, which included ELM PET FOODS brand Salmon Recipe Cat Food Formula (b)(4), Lot: TE1 01 JUNE 2021 in 7 lb. bags. This lot was distributed in interstate commerce without being assessed for food safety.
Evaluation of your response:
In your response dated October 21, 2021, you provided an updated copy of your (b)(4),” which states you will collect environmental swabs weekly and outlines corrective actions should you receive a positive result. Your SOP is not adequate because it still does not require you to evaluate affected product after receiving the initial positive swab. Additionally, if you receive a second positive, your product evaluation does not extend to product produced since the last negative test result; therefore, you are not evaluating all product that could be affected for safety.
Current Good Manufacturing Practice (CGMP) Requirements
Your animal food facility is also subject to the CGMP requirements found in 21 CFR Part 507, subparts A, B, D and F. During the inspection of your facility, FDA investigators noted evidence of violation of these requirements, as follows:
4. You failed to maintain animal food contact surfaces to protect animal food from being contaminated, as required by 21 CFR 507.22(a)(4)(iii).
Specifically,
A) During production on July 20, 2021, FDA investigators observed rubber belt material on Shaker Screens A-E which appeared to be porous and showed evidence of fraying and pitting. These areas are post lethal treatment direct food contact surfaces.
B) During production on July 23, 2021, and August 18, 2021, FDA investigators observed rust and corrosion on your aluminum scale buckets on Scale Line A and Scale Line B. These areas are post lethal treatment direct food contact surfaces.
C) During production on July 23, 2021, FDA investigators observed rust and pitting on the shaker cylinder located inside Shaker Screen A. This area is a post lethal treatment direct food contact surface.
Evaluation of your response:
Your responses dated September 23, 2021, and October 21, 2021, state:
A) The identified rubber belting material has been replaced with a non-porous material on Shaker A-E and you provided documentation of retraining of your sanitation team.
B) You have provided training to your employees on how to identify oxidation on equipment. You ordered replacement scale buckets and will work with your sanitation supply company to assess possible causes of oxidation, work towards mitigation, and develop and implement a preventive maintenance program to visually inspect post lethal treatment direct food contact surfaces for oxidation.
C) You have provided training to employees on how to look for rust, pitting, and oxidation on direct food contact pieces of equipment and you replaced the shaker cylinders with stainless steel housing.
We will verify the implementation and sustainability of your corrective actions during an inspection of your firm at a later date.
5. You failed to keep your plant clean and in good repair to prevent animal food from becoming adulterated, as required by 21 CFR 507.19(a).
During our inspection, FDA investigators observed evidence of roof leaks throughout your post-lethal treatment pet food processing areas during production and dripping onto the floor in high foot traffic areas. FDA investigators also observed rainwater running down food processing equipment during production. Specifically:
A) On July 19, 2021, apparent water droplets were observed dripping from the roof and forming a standing water puddle on the floor in the northwest corner of your packaging area approximately three feet from your E Line Packaging Equipment.
B) On July 20, 2021, apparent water droplets, dripping continuously, were observed leaking from the roof directly into a pool of standing water approximately three feet in front of your #1 Greaser equipment, which is in a post lethal treatment area of your pet food processing facility. Employees were also observed walking in this standing water puddle.
C) On July 21, 2021, and July 22, 2021, apparent water droplets were observed leaking continuously from your drop ceiling directly onto the floor of your primary employee entry and exit door to your pet food processing area. Employees were also observed walking in this standing water upon entry and exit from your pet food processing areas.
D) On July 22, 2021, water was observed dripping from the roof and forming a standing water puddle directly on the floor in the center of the employee designated walkway between the expansion room and the finished product packaging room. Employees were observed walking on this pathway through the standing water.
E) On July 22, 2021, water was observed seeping from the floor of the greaser leg basement room. The pool of standing water was also observed serving as a harborage area for approximately 40 apparent live fly insects. A water hose used for cleaning floors, walls, and post lethal treatment pet food equipment exteriors was also observed making direct contact with the floor approximately ½ -inch from the standing water.
F) On July 19, 2021, apparent water droplets were observed running down the exterior of the #2 Greaser Leg in the expansion room and forming droplets directly across an opening to a post lethal treatment direct food-contact surface.
G) On July 21, 2021, apparent water droplets were observed running down the pet food hopper of your Shaker Screen C machine. The water was observed running down the exterior of the equipment and forming a standing water puddle directly on the floor.
Evaluation of your response:
Your October 21, 2021, response includes a purchase order of a new roof over the extrusion and production area of your plant and photographs showing the roof being replaced. You also stated, “Engineering has determined that a subterranean well will need to be drilled on the outside of the basement walls. This will relieve ground water from entering the basement during excessive rainfalls. Once completed the basement walls will be injected with Dural Aqua-Dam which is a hydrophobic polyurethane grout to seal the basement from its exterior. Projected completion date is estimated to be December 1, 2021.” In addition, the response included a purchase order for supplies to complete this project. We will verify the implementation and sustainability of your corrective actions during an inspection of your firm at a later date.
Conclusion
This letter is not intended to be an all-inclusive statement of violations that may exist at your facility or in connection with your products. You are responsible for investigating and determining the causes of any violations and for preventing their recurrence or the occurrence of other violations. It is your responsibility to ensure that you comply with all requirements of federal law and FDA regulations.
This letter notifies you of our concerns and provides you an opportunity to address them. Failure to adequately address this matter may lead to legal or regulatory action, including without limitation, seizure and injunction.
Furthermore, following the review of your August 9, 2021, September 23, 2021, and October 21, 2021, responses, we have these additional comments:
1. A root cause analysis is part of a common approach to complying with the requirement that appropriate action be taken to reduce the likelihood that a problem will recur (see 21 CFR 507.42(a)(2)(ii)). Knowing the root cause is key to reducing the likelihood that a problem will happen again. To date, your responses do not include documentation showing that you have determined a root cause for the Salmonella contamination that resulted in the Class I recall on August 24, 2020.
2. Your SOP (b)(4),” establishes your limit for DON in ingredients and finished product as 5 ppm. FDA’s “Guidance for Industry and FDA: Advisory Levels for Deoxynivalenol (DON) in Finished Wheat Products for Human Consumption and Grains and Grain By-Products used for Animal Feed” states the advisory level is 5 ppm for DON on grains and grain by-products destined for “all other animals,” which includes dogs and cats, with the added recommendation that these ingredients do not exceed 40% of their diet. Your (b)(4) does not consider the finished product’s formulation when establishing your DON limit in susceptible grains.
3. In our letter to you dated July 15, 2021, we informed you it is not acceptable to use method AOAC 2009.02 (Automated Enumeration of Escherichia coli in Food) for enumeration of Enterobacteriaceae and Coliforms on environmental surfaces because there are methods available specifically for enumeration of Enterobacteriaceae and Coliforms on environmental surfaces: AOAC 2018.05 Enumeration of Enterobacteriaceae in Select Foods and Environmental Surfaces; AOAC 2018.13 Enumeration of Escherichia coli and Coliform in a Broad Range of Foods and Select Environmental Surfaces. We also informed you that environmental hygiene counts should be reported in counts per surface area (e.g., cfu/cm2 or cfu/in2). You responded that Sunshine Mills PNC laboratory is not currently accredited for AOAC 2018.05 and AOAC 2018.13. Until accreditation is achieved, you will not test micro swabs in your internal laboratory. Your revised (b)(4), provided in your October 21, 2021, response, states a third-party laboratory will be used to perform testing for Enterobacteriaceae and Coliforms. However, your SOP still states the method used will be AOAC 2009.02.
It is acceptable for you to use a third-party laboratory for enumeration of Enterobacteriaceae and E. coli/Coliform in environmental swabs. However, as previously stated, AOAC 2009.02 is not an acceptable method. Please provide confirmation that the third-party lab is using and is accredited to run AOAC 2018.05 and/or AOAC 2018.13 and that data will be reported as cfu/cm2 or cfu/in2.
4. In our letter to you dated July 15, 2021, we informed you it is not acceptable to use AOAC 2013.01 for enumeration of Yeast/Mold on environmental surfaces because AOAC 2013.01 is for the detection of Salmonella in a variety of foods and not for enumeration of Yeast/Mold on environmental surfaces. We also informed you that environmental hygiene counts should be reported in counts per surface area (e.g., cfu/cm2 or cfu/in2). You responded that Sunshine Mills PNC laboratory is not accredited for the enumeration of Yeast/Mold on environmental surfaces. Until accreditation is achieved, you will be sending your micro swabs to a third-party testing laboratory with the appropriate testing capabilities.
Your revised (b)(4), provided in your October 21, 2021, response states method AOAC 2009.02 will be used by the third-party laboratory for the enumeration of Yeast/Mold. It is acceptable for you to use a third-party laboratory for enumeration of Yeast/Mold in environmental swabs. However, AOAC 2009.02 is for Automated Enumeration of Escherichia coli in Food and is not an acceptable method for the enumeration of Yeast/Mold. Please provide confirmation the third-party laboratory is using an accredited method for the enumeration of Yeast/Mold in environmental swabs, the lab is accredited to run the method, and the results will be reported as cfu/cm2 or cfu/in2.
5. In our letter dated July 15, 2021, we asked you to provide information on what your ATP baseline levels were and how you derived your acceptable ATP limits. You responded August 9, 2021, that ATP limits were based on the manufacturer’s guidelines as outlined in the manufacturer’s brochures. However, you did not provide documentation to support your RLU limits listed in (b)(4).” Also, please confirm which (b)(4) you use, as the default upper and lower RLU limits of (b)(4) are different from the ones of (b)(4).
Additionally, the reference you provided, “(b)(4),” is for hands and not relevant/applicable for environmental surfaces. This is not an acceptable reference for determining ATP limits for surface testing.
Within fifteen (15) working days of receipt of this letter, please notify this office in writing of the specific steps that you have taken to correct any violations. Include an explanation of each step being taken to prevent the recurrence of violations, as well as copies of related documentation. If you cannot complete corrective actions within fifteen (15) working days, state the reason for the delay and the time frame within which you will complete the correction. If you believe that you have complied with the FD&C Act and FDA regulations, include your reasoning and any supporting information for our consideration. In addition, please be prepared to discuss your reasoning and any supporting information during our upcoming teleconference regulatory meeting.
Please send your firm’s response to Allison C. Hunter, Compliance Officer, U.S. Food and Drug Administration, 550 Main Street, Suite 500, Cincinnati, OH 45202 or via email to ORAHAFEAST5FirmResponses@fda.hhs.gov. If you have questions regarding any issues in this letter, please contact Allison Hunter at 513-322-0629 or via email at Allison.Hunter@fda.hhs.gov.
Sincerely,
/S/
Steven B. Barber
Cincinnati District Director
Office of Human and Animal Food Operations
Division East 5
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