Did not identify environmental pathogens as a food safety hazard in processing of RTE product with exposure.
- "Did not consider contamination with environmental pathogens as a potential food safety hazard at the Mixing or Packaging/Sealing step to evaluate whether it requires a preventive control."
Examples of poor practices when handling RTE food
"an employee was observed to touch an electrical control panel (which is not cleaned between production runs within a production day), dump a tumbler filled with RTE seasoned pretzels into a plastic bucket, scoop a handful of these seasoned pretzels from the bucket with their gloved hand, and place them back into the tumbler. The same employee then proceeded to open a box of pretzels including the interior bag and scoop those pretzels with a gloved hand into a plastic pitcher before placing those pretzels into the tumbler.""During production of Pop Daddy Dill Pickle pretzels (Lot # 22822.1), plastic buckets containing RTE seasoned pretzels were sitting atop flattened cardboard on the floor. A bucket was observed slightly overhanging the cardboard and partially exposed to the floor. An employee’s hands were observed to touch the bottom of the buckets while emptying them into a packaging hopper, in the process also touching the inside of the buckets. The employee then placed the buckets under the mixing tumbler to fill with the next batch of RTE seasoned pretzels, without the buckets being washed or sanitized."
Did not verify the effectiveness of this preventive control by performing environmental monitoring
- "We note that your SOP titled “Environmental Monitoring,” dated October 24, 2018, states that you must (b)(4) take sample swabs at various points of the production process. However, during the inspection your management told FDA investigators that you do not recognize environmental swabbing as a verification of your sanitation controls. In addition, your environmental monitoring SOP did not identify the number of sites to be tested during routine environmental monitoring, the timing for collecting samples, or the test(s) conducted including the analytical method(s) used, as required by 21 CFR 117.165(b)(3)(iii-v)."
- "Did not always follow your procedure. A review of your environmental monitoring results from 2020, 2021, and 2022 (in which you collected (b)(4) swabs respectively on (b)(4) as part of your routine sampling program) found that you frequently obtained results that exceeded your TPC limit of (b)(4) cfu/swab. For example, your 2021 environmental monitoring obtained results of (b)(4) cfu on (b)(4), (b)(4) cfu on (b)(4), and (b)(4) cfu on (b)(4) for the (b)(4) faucet handle. Also, your 2022 environmental monitoring obtained results of (b)(4) cfu on (b)(4) and (b)(4) cfu on (b)(4) for the warehouse worktable. In both cases, upon obtaining unacceptable TPC results, you took follow-up samples, which still indicated unacceptable TPC levels. There is no indication that you took any further action to bring the TPC level down to an acceptable level."
Supplier Preventive Controls for ingredients used in RTE applications
- The "pretzel hazard analysis in your food safety plan, dated March 21, 2022, did not consider pathogens such as Salmonella in your RTE seasoning ingredients to determine whether they require a preventive control. Your process does not apply a lethal treatment to any of your incoming raw materials and ingredients used in production of your RTE pretzels. Some of these seasoning ingredients (e.g., garlic parmesan, dill, and cinnamon) have been associated with pathogens such as Salmonella.
- During the inspection, the most recent survey and audit certificate from (b)(4), your supplier for garlic parmesan seasoning, was reviewed. However, the certificate was issued on May 11, 2021, so it was already three months past the annual audit timeframe required by your supply-chain procedure when we reviewed the certificate. Salmonella in RTE pretzels is a hazard that can cause serious adverse health consequences or death and thus an annual onsite audit is the appropriate supplier verification activity unless there is a written determination that other verification activities and/or less frequent onsite auditing of the supplier provide adequate assurance that the hazard is controlled (see 21 CFR 117.430(b)). The audit must be conducted before using the raw material or other ingredient from the supplier and at least (b)(4) thereafter (see 21 CFR 117.430(b)(1)(ii)).
Allergen Preventive Controls
- The "inspection revealed that your preventive controls qualified individual (or an individual under the oversight of your preventive controls qualified individual) was not reviewing your allergen monitoring records to verify that the label checks were operating as intended"
WARNING LETTER
Pop Daddy Popcorn, LLC
MARCS-CMS 646807 — MARCH 28, 2023
Pop Daddy Popcorn, LLC
MARCS-CMS 646807 — MARCH 28, 2023
Recipient:
Mark T Sarafa
Managing Member/President/Co-owner
Pop Daddy Popcorn, LLC
11234 Lemen Industrial Dr. Ste C
Whitmore Lake, MI 48189
United States
mark.sarafa@popdaddysnacks.com
Issuing Office:
Division of Human and Animal Food Operations East VI
United States
WARNING LETTER
FY23-HAFE6-03 CMS 646807
03/28/2023
Dear Mr. Sarafa:
The United States Food and Drug Administration (FDA) inspected your manufacturing facility located at 11234 Lemen Industrial Dr. Ste C, Whitmore Lake, MI from August 9, 2022 through September 2, 2022. The inspection covered ready-to-eat (RTE) seasoned hard pretzels. During this inspection, 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). At the conclusion of the inspection, FDA issued a Form FDA 483, Inspectional Observations (Form FDA 483), listing violations found at your facility.
The inspection revealed that RTE pretzels manufactured in your facility are adulterated within the meaning of section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act (the Act) [21 United States Code (U.S.C) § 342(a)(4)], in that they were prepared, packed, or held under insanitary conditions whereby they may have become contaminated with filth or 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, B, 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 can find the Act and applicable regulations through links in FDA’s Internet homepage at www.fda.gov.External Link Disclaimer
We received your written response, dated September 12, 2022, which included a summary of corrective actions by your facility and associated documentation. After reviewing the inspectional findings and your response to the observations listed in the Form FDA 483, we are issuing this letter to advise you of FDA’s continuing concerns and provide detailed information describing the findings at your facility. We also address your response below.
Hazard Analysis and Risk-Based Preventive Controls (21 CFR Part 117, Subpart C):
1.You did not identify and evaluate all known or reasonably foreseeable hazards to determine whether there are hazards requiring a preventive control for your RTE pretzels, as required by 21CFR 117.130(a)(1). Specifically:
a. Your pretzel hazard analysis in your food safety plan, dated March 21, 2022, did not consider contamination with environmental pathogens as a potential food safety hazard at the Mixing or Packaging/Sealing step to evaluate whether it requires a preventive control. After exposure to the environment at the Mixing and Packaging/Sealing steps, the pretzels do not receive a lethal treatment or otherwise include a control measure (such as a formulation lethal to the pathogen) that would significantly minimize pathogens. Therefore, contamination with environmental pathogens is a known or reasonably foreseeable hazard. Further, a knowledgeable person manufacturing/processing food in your circumstances would identify contamination with environmental pathogens as requiring a preventive control. Preventive controls include procedures, practices, and processes to ensure that the facility is maintained in a sanitary condition adequate to significantly minimize or prevent hazards such as environmental pathogens (see 21 CFR 117.135(c)(3)).
We note that on the following two separate instances during the inspection your employees were observed touching non-food-contact surfaces before directly handling food and/or food-contact surfaces, without washing/sanitizing their hands or changing their gloves.
i. During production of (b)(4) Garlic Parmesan pretzels (Lot # (b)(4)) on the (b)(4) line, an employee was observed to touch an electrical control panel (which is not cleaned between production runs within a production day), dump a tumbler filled with RTE seasoned pretzels into a plastic bucket, scoop a handful of these seasoned pretzels from the bucket with their gloved hand, and place them back into the tumbler. The same employee then proceeded to open a box of pretzels including the interior bag and scoop those pretzels with a gloved hand into a plastic pitcher before placing those pretzels into the tumbler.
ii. During production of Pop Daddy Dill Pickle pretzels (Lot # 22822.1), plastic buckets containing RTE seasoned pretzels were sitting atop flattened cardboard on the floor. A bucket was observed slightly overhanging the cardboard and partially exposed to the floor. An employee’s hands were observed to touch the bottom of the buckets while emptying them into a packaging hopper, in the process also touching the inside of the buckets. The employee then placed the buckets under the mixing tumbler to fill with the next batch of RTE seasoned pretzels, without the buckets being washed or sanitized.
When contamination with environmental pathogens is a hazard requiring a prevention control, you must verify the effectiveness of this preventive control by performing environmental monitoring (see 21 CFR 117.165(a)(3)). We note that your SOP titled “Environmental Monitoring,” dated October 24, 2018, states that you must (b)(4) take sample swabs at various points of the production process. However, during the inspection your management told FDA investigators that you do not recognize environmental swabbing as a verification of your sanitation controls. In addition, your environmental monitoring SOP did not identify the number of sites to be tested during routine environmental monitoring, the timing for collecting samples, or the test(s) conducted including the analytical method(s) used, as required by 21 CFR 117.165(b)(3)(iii-v).
Additionally, we note that your environmental monitoring SOP indicates that you sample for Salmonella/Listeria, Yeast/Mold, and Total Plate Count (TPC). Your environmental monitoring SOP requires you to take a number of actions when samples are found above certain acceptable levels (including analyzing the affected areas, cleaning and sanitizing the affected surfaces, reviewing the cleaning procedures, and the option of conducting a root cause analysis for continued failures). The SOP also requires you to collect follow-up samples “(b)(4).” However, you did not always follow your procedure. A review of your environmental monitoring results from 2020, 2021, and 2022 (in which you collected (b)(4) swabs respectively on (b)(4) as part of your routine sampling program) found that you frequently obtained results that exceeded your TPC limit of (b)(4) cfu/swab. For example, your 2021 environmental monitoring obtained results of (b)(4) cfu on (b)(4), (b)(4) cfu on (b)(4), and (b)(4) cfu on (b)(4) for the (b)(4) faucet handle. Also, your 2022 environmental monitoring obtained results of (b)(4) cfu on (b)(4) and (b)(4) cfu on (b)(4) for the warehouse worktable. In both cases, upon obtaining unacceptable TPC results, you took follow-up samples, which still indicated unacceptable TPC levels. There is no indication that you took any further action to bring the TPC level down to an acceptable level.
Your response provided an updated food safety plan including a pretzel hazard analysis, dated September 9, 2022. However, the updated hazard analysis still does not identify contamination with environmental pathogens as a hazard requiring a preventive control at the Mixing and Packaging/Sealing steps.
In addition, your response stated that you are reviewing environmental monitoring procedures with regards to frequency, number, and locations for sampling. It indicated that once production has begun in your new facility, you will implement an updated risk-based procedure and zone map. We cannot evaluate the adequacy of these actions because you have not provided an updated environmental monitoring procedure for FDA review.
b. Your pretzel hazard analysis in your food safety plan, dated March 21, 2022, did not consider pathogens such as Salmonella in your RTE seasoning ingredients to determine whether they require a preventive control. Your process does not apply a lethal treatment to any of your incoming raw materials and ingredients used in production of your RTE pretzels. Some of these seasoning ingredients (e.g., garlic parmesan, dill, and cinnamon) have been associated with pathogens such as Salmonella. Therefore, the pathogen of Salmonella is a known or reasonably foreseeable hazard. Further, a knowledgeable person manufacturing/processing food in your circumstances would identify pathogens as a hazard requiring a preventive control in these ingredients. Because these hazards are controlled at your suppliers, the appropriate type of control is a supply-chain control. A facility that identifies raw materials and other ingredients with hazards such as Salmonella that require a supply-chain-applied control must establish and implement a risk-based supply-chain program for those raw materials and ingredients (see 21 CFR 117.405(a)(1)). The supply-chain program must include using approved suppliers and conducting supplier verification activities (see 21 CFR 117.410).
You maintain a supply-chain procedure whereby you conduct (b)(4) supply chain surveys and collect third-party audits and/or certifications of your suppliers. As part of this procedure, you collect information regarding food safety hazards in raw materials received from suppliers. During the inspection, the most recent survey and audit certificate from (b)(4), your supplier for garlic parmesan seasoning, was reviewed. However, the certificate was issued on May 11, 2021, so it was already three months past the annual audit timeframe required by your supply-chain procedure when we reviewed the certificate. Salmonella in RTE pretzels is a hazard that can cause serious adverse health consequences or death and thus an annual onsite audit is the appropriate supplier verification activity unless there is a written determination that other verification activities and/or less frequent onsite auditing of the supplier provide adequate assurance that the hazard is controlled (see 21 CFR 117.430(b)). The audit must be conducted before using the raw material or other ingredient from the supplier and at least (b)(4) thereafter (see 21 CFR 117.430(b)(1)(ii)).
Your response provided an updated food safety plan including your pretzel hazard analysis, dated September 9, 2022. The updated hazard analysis identifies Salmonella at the Receiving Ingredients step as a hazard requiring a preventive control. Your updated Supply-chain Preventive Control requires that “All raw materials received have the proper supplier docs: COAs, letters of guarantee, copies of third-party audits and/or certification”. Further, your response stated that you received copies of your supplier audit certificates and reports. However, we cannot evaluate the adequacy of your corrective actions because, while your response included a supplier letter of guarantee for aflatoxin, you have not provided any supplier documentation relevant to the Salmonella hazard for FDA review. In particular, you have not provided documentation showing that you have reviewed more recent audits results covering the Salmonella hazard for garlic parmesan seasoning received from your supplier, (b)(4).
2. You did not implement your 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 misbranded under section 403(w) of the Act, as required by 21 CFR 117.135(a)(1). Specifically, you did not follow your “Allergen Preventive Controls” in your food safety plan for pretzels. Your pretzels contain allergens, including wheat and milk.
Your pretzel hazard analysis in your food safety plan, dated March 21, 2022, concluded that “Allergen Labeling” is a food safety hazard requiring a preventive control at the “Labeling/Date Coding” step because “Proper labeling for all allergens is required.” At the “Labeling/Date Coding” step, your food safety plan requires the preventive control of monitoring for “Proper labeling… for correct allergens.” However, during the inspection, FDA investigators found that your label checks were looking for correct foreign language on labels (for example, checking that product shipped to Canada has English-language and French-language packaging) and not for correct allergen declarations.
Additionally, we note that the inspection revealed that your preventive controls qualified individual (or an individual under the oversight of your preventive controls qualified individual) was not reviewing your allergen monitoring records to verify that the label checks were operating as intended, as required by 21 CFR 117.165(a)(4)(i). Specifically, your “Daily Packaging/Date Check” records were not reviewed on February 4, 2022; March 24, 2022; April 22, 2022; May 31, 2022; June 8, 2022; July 21, 2022; or August 16, 2022.
Your response provided retraining documentation to show that managers had been retrained on how allergen label checks should be performed. You also provided an updated “Daily Packaging/Date Check” form that specifies that proper packaging is used for products, including the statement “This includes checking allergen statements on the packaging.” However, we cannot fully evaluate the adequacy of your corrective actions because the form you provided was left blank, so we cannot assess how or if you have implemented your new label check procedure.
This letter is not intended to be an all-inclusive list of violations that may exist in connection with your products. You are responsible for investigating and determining the causes of any violations identified above and for preventing their recurrence or the occurrence of other violations. It is your responsibility to ensure that your firm complies with all requirements of federal law, including FDA regulations.
This letter notifies you of our concerns and provides you with an opportunity to address them. Failure to adequately address this matter may result in legal action without further notice, including, without limitation, seizure, and injunction.
Please notify FDA in writing, within 15 working days of receipt of this letter, of the specific steps you have taken to address these 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 15 working days, state the reason for the delay and the timeframe within which you will do so. If you believe that your products are not in violation of the Act, include your reasoning and any supporting information for our consideration.
Your reply should be addressed to the U.S. Food and Drug Administration; Attn: Dylan Grippi, Compliance Officer, via email at ORAHAFEAST6FirmResponses@fda.hhs.gov or at 300 River Place Dr. Suite#5900, Detroit, MI 49207. You may reach Mr. Grippi at 301-452-1608 or via email at Dylan.Grippi@fda.hhs.gov if you have any questions about this matter.
Sincerely,
/S/
William R. Weissinger, MS
Program Division Director
Office of Human and Animal Food Operations
Division East 6
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