FDA Issues Warning Letter to Manufacturer of RTE Ingredient

FDA issued a Warning Letter to an Ohio firm that manufacturers RTE ingredients.  The problem was that the firm had a Listeria issue (discovered by their customer who tested the product and probably reported via the Reportable Food Registry).  Upon inspection by the FDA, the firm did not have good cleaning procedures and was not responding to Listeria positive samples.  The firm did not not implement effective corrective action procedures to include that root cause analysis, specifically - "did not perform an investigation to locate a potential source of contamination or make any changes to your sanitation practices."  The firm also had some poor practices including the use of high pressure hoses as well as improper cleaning of transfer pipes.

From the Letter

• "Specifically, your food safety plan identified environmental pathogens as a hazard requiring preventive controls and identified sanitation controls to address the hazard, but you did not fully implement your “Sanitation Standard Operating procedure (SSOP), We also gathered documentation that one of your customers tested and found your aji amarillo paste to be positive for L. monocytogenes." 
• "In addition, a review of records of your weekly environmental monitoring program for Listeria spp. shows that (b)(4).  (b)(4) collected by FDA during our most recent inspection were positive for L. monocytogenes. Furthermore, your finished aji amarillo paste product was found to be positive for L. monocytogenes (b)(4)."
• "Whole genome sequencing analysis showed the L. monocytogenes isolates from the environmental swabs collected by FDA were the same strain as that in the finished product aji amarillo paste tested by your customer. Your environmental testing results and these findings demonstrate that your sanitation procedures have been inadequate to significantly minimize or prevent the hazard of L. monocytogenes in your facility"
•  "You did not implement your written corrective action procedures to address the presence of an environmental pathogen or appropriate indicator organism detected through your environmental monitoring, as required by 21 CFR 117.150(a)(1)(ii). Specifically, in your food safety plan, you identified (b)(4). (Environmental monitoring is a verification activity for preventive controls as reflected in 21 CFR 117.165(a)(3).) Your environmental monitoring program lists the following corrective actions after a presumptive positive for Listeria spp.: (b)(4). Your weekly environmental monitoring program for Listeria spp. (b)(4). Each time, your corrective actions were limited to (b)(4). You did not perform an investigation to locate a potential source of contamination or make any changes to your sanitation practices."
• "You did not clean and sanitize utensils and equipment in a manner that protects against allergen cross-contact and against contamination of food, food-contact surfaces, or food-packaging materials, as required by 21 CFR 117.35(a). On March 28, 2019, our investigator observed an employee using a high-pressure hose to spray the mezzanine floor with water while performing sanitation operations. Water overspray created a mist surrounding the open medium ribbon blender used to manufacture aji amarillo paste. On April 2, 2019, our investigator observed water overspray around the blue (b)(4) pallets on which employees were cleaning product transfer hoses, (b)(4) blades, a (b)(4), (b)(4) hopper, and (b)(4) fixtures used in the manufacture of the aji amarillo paste. Our investigator also observed an employee cleaning a product transfer pipe without cleaning the full interior of the pipe."

FDA Warning letter
https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/yost-foods-inc-581473-09102019
Yost Foods, Inc 
MARCS-CMS 581473 — September 10, 2019


Product:  Food & Beverages

Recipient:
William L. Yost
President
Yost Foods, Inc
2795 Westway Drive
Brunswick, OH 44212
United States

Issuing Office:
Cincinnati District Office
United States


September 10, 2019
WARNING LETTER #581473

Dear Mr. Yost:
The United States Food & Drug Administration (FDA) inspected your Ready-to-Eat (RTE) spice manufacturing facility, located at 2795 Westway Drive, Brunswick, Ohio from March 18 through April 24, 2019. During our inspection of your facility, FDA investigators found serious violations of the Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food regulation (CGMP & PC rule), Title 21, Code of Federal Regulations, Part 117 (21 CFR Part 117). Additionally, FDA collected environmental samples from various areas in your processing facility. FDA laboratory analysis of the environmental samples (i.e., swabs) found the presence of Listeria monocytogenes (L. monocytogenes), a human pathogen, in your facility. We also gathered documentation that one of your customers tested and found your aji amarillo paste to be positive for L. monocytogenes. (We are aware that subsequently you voluntarily recalled and destroyed the product.)
Based on FDA’s inspectional findings and the analytical results for the environmental and food samples, we determined that food manufactured in your facility is adulterated within the meaning of Section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act (the Act) [21 U.S.C. § 342(a)(4)] in that it was prepared, packed or held under insanitary conditions whereby it may have been rendered injurious to health.
In addition, failure of the owner, operator, or agent in charge of a covered facility to comply with the preventive controls provisions of the CGMP & PC rule (located in subparts A, C, D, E, F, and G of part 117) is prohibited by Section 301(uu) of the Act [21 U.S.C. § 331(uu)]. You may find the Act and further information about the CGMP & PC rule through links in FDA’s home page at http://www.fda.gov.
FDA’s inspection resulted in issuance of an FDA Form-483 (FDA-483), Inspectional Observations, listing violations found during our inspection. We received your response to the

FDA-483 on May 14, 2019, in which you described corrective actions taken by your firm. Your response included a Hazard Analysis, Sanitation Standard Operating Procedures (SSOPs) and a Sanitation Pre-Operational Checklist. We address your response below.
We found the following significant violations:

Hazard Analysis and Risk-Based Preventive Controls (21 CFR Part 117, Subpart C):
1. You did not implement preventive controls to provide assurances that any hazards requiring a preventive control will be significantly minimized or prevented, and the food manufactured, processed, packed, or held by your facility will not be adulterated under section 402 or misbranded under section 403(w) of the Act (21 U.S.C. §§ 342 or 343(w)), to comply with 21 CFR § 117.135(a)(1). Specifically, your food safety plan identified environmental pathogens as a hazard requiring preventive controls and identified sanitation controls to address the hazard, but you did not fully implement your “Sanitation Standard Operating procedure (SSOP), Yost Foods, Inc, Food Basics.” Your SSOP specifies that (b)(4). Our investigator observed that the QA review occurred after cleaning but prior to the (b)(4) step. Further, your SSOP states (b)(4). However, your records dated February 22, 2019, April 1, 2019, and April 3, 2019, only document rinsing of the equipment during corrective actions.
In addition, a review of records of your weekly environmental monitoring program for Listeria spp. shows that (b)(4).  (b)(4) collected by FDA during our most recent inspection were positive for L. monocytogenes. Furthermore, your finished aji amarillo paste product was found to be positive for L. monocytogenes (b)(4). Whole genome sequencing analysis showed the L. monocytogenes isolates from the environmental swabs collected by FDA were the same strain as that in the finished product aji amarillo paste tested by your customer. Your environmental testing results and these findings demonstrate that your sanitation procedures have been inadequate to significantly minimize or prevent the hazard of L. monocytogenes in your facility, as required by 21 CFR §§ 117.135(a)(1) and (c)(3).
L. monocytogenes is a pathogenic bacterium that is widespread in the environment and may be introduced into a food processing facility from raw materials, humans or equipment. Without proper controls, it can proliferate in food processing facilities where it may contaminate food. Consuming foods contaminated with L. monocytogenes can lead to a severe, sometimes life-threatening, illness called listeriosis, an atypical foodborne illness, which is a major public health concern due to the severity of the disease, its high case-fatality rate, long incubation time, and tendency to affect older adults, pregnant women, newborns, and adults with weakened immune systems.
We have reviewed your May 14, 2019 response indicating that your firm is implementing a number of corrective actions, including updating your cleaning procedures, updating your Sanitation Pre-Operational Checklist, hiring a sanitation consultant to re-train associates on proper cleaning technique, reassessing your food safety plan, conducting additional sanitation activities, and testing environmental swabs for L. monocytogenes. We will verify the adequacy of your corrective actions during a future inspection.
2. You did not implement your written corrective action procedures to address the presence of an environmental pathogen or appropriate indicator organism detected through your environmental monitoring, as required by 21 CFR 117.150(a)(1)(ii). Specifically, in your food safety plan, you identified (b)(4). (Environmental monitoring is a verification activity for preventive controls as reflected in 21 CFR 117.165(a)(3).) Your environmental monitoring program lists the following corrective actions after a presumptive positive for Listeria spp.: (b)(4). Your weekly environmental monitoring program for Listeria spp. (b)(4). Each time, your corrective actions were limited to (b)(4). You did not perform an investigation to locate a potential source of contamination or make any changes to your sanitation practices.
We have reviewed your May 14, 2019 response indicating that your firm has updated your Environmental Pathogen Monitoring Program to include corrective action and investigation procedures. We will verify the adequacy of your corrective actions during a future inspection.
Current Good Manufacturing Practice (Subpart B):
1. You did not clean and sanitize utensils and equipment in a manner that protects against allergen cross-contact and against contamination of food, food-contact surfaces, or food-packaging materials, as required by 21 CFR 117.35(a). On March 28, 2019, our investigator observed an employee using a high-pressure hose to spray the mezzanine floor with water while performing sanitation operations. Water overspray created a mist surrounding the open medium ribbon blender used to manufacture aji amarillo paste. On April 2, 2019, our investigator observed water overspray around the blue (b)(4) pallets on which employees were cleaning product transfer hoses, (b)(4) blades, a (b)(4), (b)(4) hopper, and (b)(4) fixtures used in the manufacture of the aji amarillo paste. Our investigator also observed an employee cleaning a product transfer pipe without cleaning the full interior of the pipe.
We have reviewed your May 14, 2019 response indicating that your firm has updated your cleaning procedures and hired a sanitation consultant to re-train associates on proper cleaning technique. We will verify the adequacy of your corrective actions during a future inspection.

This letter is not intended to be an all-inclusive list of violations at your facility or in connection with your products. You are responsible for ensuring that your facility operates in compliance with federal law, including the Act, the CGMP & PC rule, and other applicable FDA regulations. You should take prompt action to correct the violations noted in this letter. Failure to do so may result in legal action by the FDA without further notice, including, without limitation, seizure and injunction.
Please notify this office in writing within fifteen (15) working days of the receipt of this letter as to the specific steps you have taken to correct the stated violations, including an explanation of each step being taken to identify violations and make corrections to ensure that similar violations will not recur. In your response, you should include documentation, including revised procedures, photographs, results of tests you have conducted, and other useful information that would assist us in evaluating your corrections. If you do not believe that your products are in violation of the Act, include your reasoning and any supporting information for our consideration. If the corrective action cannot be completed within fifteen working days, state the reason for the delay and the time frame within which the corrections will be implemented.
Section 743 of the Act, (21 U.S.C. 379j-31), authorizes FDA to assess and collect fees to cover FDA’s costs for certain activities, including re-inspection-related costs. A re-inspection is one or more inspections conducted subsequent to an inspection that identified non-compliance materially related to a food safety requirement of the Act, specifically to determine whether compliance has been achieved. Re-inspection-related costs means all expenses, including administrative expenses incurred in connection with FDA’s arranging, conducting, and evaluating the results of the re-inspection and assessing and collecting the re-inspection fees, [21 U.S.C. 379j-31(a)(2)(B)]. For a domestic facility, FDA will assess and collect fees for re-inspection-related costs from the responsible party for the domestic facility. The inspection noted in this letter identified non-compliance materially related to a food safety requirement of the Act. Accordingly, FDA may assess fees to cover any re-inspection-related costs.
Your written response should be sent to Stephen J. Rabe, Compliance Officer, ORAHAFEAST5FirmResponses@fda.hhs.gov. If you have questions regarding any issues in this letter, please contact Mr. Rabe at 513-679-2700, extension 2163 or via email at Stephen.rabe@fda.hhs.gov.
Sincerely,
/S/
Steven B. Barber
Director, Division 5
Office of Human and Animal Foods Operations East