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

Source: https://www.keypedia.com/records/warning_letter/frito-lay-inc/809fed5c-4036-46f1-abe4-e5634cf3a8bb

> FDA WARNING_LETTER for Frito Lay, Inc on September 29, 2020. Product: Food. Access full analysis and detailed observations.

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## Details

- Record Type: WARNING_LETTER
- Company Name: Frito Lay, Inc
- Inspection Date: 2020-09-29
- Product Type: Food
- Office Name: Division of Human and Animal Food Operations - West III
- Summary: 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"

## Related Officers

- [Director](https://www.keypedia.com/people/lori-woznicki/41fabd4c-c917-439b-a6cb-d21ee3552cab)
- [Program Director](https://www.keypedia.com/people/edmundo-garcia/d47fc6d7-1ed9-4a65-bcaf-b3860041ca55)

Company: https://www.keypedia.com/companies/frito-lay-inc/08d0f2d2-597a-4795-a3ef-71d064aace75

Office: https://www.keypedia.com/offices/division-of-human-and-animal-food-operations-west-iii/2cda09a5-06c4-433f-9df0-0d7903a6efab