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
