FDA WARNING_LETTER - Frito Lay, Inc - September 29, 2020

The FDA inspected potato chip manufacturing facilities in Bakersfield, CA (September 21-25, 2020) and Vancouver, WA (September 16-29, 2020) following Class I recalls. The Bakersfield recall was due to undeclared milk allergen in Lay’s Barbecue Flavored Potato Chips, and the Vancouver recall involved Ruffles Original bags containing Ruffles Cheddar & Sour Cream Potato Chips (undeclared milk).

Violations of the Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food regulation (21 CFR Part 117) were identified. The Bakersfield facility's recalled chips were deemed adulterated under 21 U.S.C. § 342(a)(4) due to insanitary conditions. The Vancouver facility's mislabeled chips were misbranded under 21 U.S.C. § 343(w) for failing to declare milk, a major food allergen.

Specific deficiencies included failure to implement adequate food allergen controls (21 CFR 117.135(a)(1) and (c)(2)). At Vancouver, the "Film Splice Tracking" and "Job Aid for Package Quality & Regulatory Certification/Weaklink" procedures were not followed, leading to incorrect film usage and product verification errors. At Bakersfield, the "(b)(4) for Seasoning Allergens SSOP"