FDA WARNING_LETTER - Pop Daddy Popcorn, LLC - September 02, 2022

The FDA inspected Pop Daddy Pretzels' facility in Whitmore Lake, MI, from August 9 to September 2, 2022, finding serious violations of the CGMP & PC rule (21 CFR Part 117) for ready-to-eat (RTE) seasoned hard pretzels. The inspection revealed adulterated products under 21 U.S.C. § 342(a)(4) due to insanitary conditions.

Key violations include: 1. **Inadequate Hazard Analysis (21 CFR 117.130(a)(1)):** * Failure to identify environmental pathogens as a hazard requiring preventive control at mixing and packaging steps, despite observations of employees touching non-food-contact surfaces and then food/food-contact surfaces without handwashing/glove changes. * Failure to adequately implement environmental monitoring, including not recognizing swabbing as verification, and not specifying the number of sites, timing, or analytical methods (21 CFR 117.165(b)(3)(iii-v)). The firm also failed to take further action when TPC levels exceeded limits. * Failure to identify pathogens (e.g., Salmonella) in RTE seasoning ingredients as a hazard requiring a supply-chain preventive control (21 CFR 117.405(a)(1)). The firm's supplier audit certificate for