As part of its enforcement activities, the Food and Drug Administration sends warning letters to entities under its jurisdiction. Some letters are not posted for public view until weeks or months after they are sent. Business owners have 15 days to respond to FDA warning letters. Warning letters often are not issued until a company has been given months to years to correct problems.
Pop Daddy Popcorn LLC
Whitmore Lake, MI
A food firm in Michigan is on notice from the FDA for serious violations of the Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food regulation. The inspection revealed that ready-to-eat pretzels manufactured in the facility are adulterated, 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 a March 28, 2023, warning letter, the FDA described an Aug. 9 through Sept. 2, 2022, FDA inspection of Pop Daddy Popcorn LLC’s manufacturing facility in Whitmore Lake, MI.
The FDA’s inspection revealed that the firm was not in compliance with regulations and resulted in the issuance of an FDA Form 483.
Significant violations:
Hazard Analysis and Risk-Based Preventive Controls:
1. The firm did not identify and evaluate all known or reasonably foreseeable hazards to determine whether there are hazards requiring a preventive control for their RTE pretzels, as required. Specifically:
a. The firm’s pretzel hazard analysis in their 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 their 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.
The FDA notes that on the following two separate instances during the inspection their 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 (redacted) Garlic Parmesan pretzels on the (redacted) 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, 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, they must verify the effectiveness of this preventive control by performing environmental monitoring. FDA notes that their SOP titled “Environmental Monitoring,” dated Oct. 24, 2018, states that they must (redacted) take sample swabs at various points of the production process. However, during the inspection their management told FDA investigators that they do not recognize environmental swabbing as a verification of theur sanitation controls. In addition, their 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.
Additionally, FDA notes that their environmental monitoring SOP indicates that they sample for Salmonella/Listeria, Yeast/Mold, and Total Plate Count (TPC). The firm’s environmental monitoring SOP requires them to take a number of actions when samples are found above certain acceptable levels. The SOP also requires them to collect follow-up samples “(redacted).” However, they did not always follow their procedure. A review of their environmental monitoring results from 2020, 2021, and 2022 (in which they collected (redacted) swabs respectively on (redacted) as part of their routine sampling program) found that they frequently obtained results that exceeded their TPC limit of (redacted) cfu/swab. For example, their 2021 environmental monitoring obtained results of (redacted) cfu on (redacted), (redacted) cfu on (redacted), and (redacted) cfu on (redacted) for the (redacted) faucet handle. Also, their 2022 environmental monitoring obtained results of (redacted) cfu on (redacted) and (redacted) cfu on (redacted) for the warehouse worktable. In both cases, upon obtaining unacceptable TPC results, they took follow-up samples, which still indicated unacceptable TPC levels. There is no indication that they took any further action to bring the TPC level down to an acceptable level.
b. The firm’s pretzel hazard analysis in their food safety plan, dated March 21, 2022, did not consider pathogens such as Salmonella in their RTE seasoning ingredients to determine whether they require a preventive control. Their process does not apply a lethal treatment to any of their incoming raw materials and ingredients used in production of their 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 their circumstances would identify pathogens as a hazard requiring a preventive control in these ingredients. Because these hazards are controlled at their 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. The supply-chain program must include using approved suppliers and conducting supplier verification activities.
The firm maintains a supply-chain procedure whereby they conduct (redacted) supply chain surveys and collect third-party audits and/or certifications of their suppliers. As part of this procedure, they collect information regarding food safety hazards in raw materials received from suppliers. During the inspection, the most recent survey and audit certificate from (redacted), their 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 their 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. The audit must be conducted before using the raw material or other ingredient from the supplier and at least (redacted) thereafter.
2. The firm did not implement their 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 their facility will not be misbranded, as required. Specifically, they did not follow their “Allergen Preventive Controls” in their food safety plan for pretzels. Their pretzels contain allergens, including wheat and milk.
Their pretzel hazard analysis in their 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, their food safety plan requires the preventive control of monitoring for “Proper labeling… for correct allergens.” However, during the inspection, FDA investigators found that their 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, FDA notes that the inspection revealed that their preventive controls qualified individual (or an individual under the oversight of their preventive controls qualified individual) was not reviewing their allergen monitoring records to verify that the label checks were operating as intended, as required. Specifically, their “Daily Packaging/Date Check” records were not reviewed on Feb. 4, 2022; March 24, 2022; April 22, 2022; May 31, 2022; June 8, 2022; July 21, 2022; or Aug. 16, 2022.
The full warning letter can be viewed here.
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