Buffalo Gills LLC – FDA Warning Letter, Sep 4, 2014

On November 26, 2014, the FDA issued a Warning Letter to Buffalo Gills, LLC, following an inspection from August 11 to September 4, 2014. The inspection revealed serious deviations from regulations for acidified foods (21 CFR Part 108 and Part 114), rendering products adulterated under section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act (the Act).

Key violations include: 1. **Failure to file scheduled processes:** The firm did not provide FDA with scheduled process information for numerous acidified food products (e.g., Roasted Garlic Butter Sauce, Mild Sauce, Hot Sauce) and has been manufacturing them since at least August 2011 without registering with the FDA, as required by 21 CFR 108.25(c)(2) and (c)(1). 2. **Lack of qualified process authority:** Scheduled processes for several acidified products were not established or evaluated by a qualified person (21 CFR 114.83). 3. **Unsupervised pH control:** Personnel involved in pH control and critical factors were not supervised by an FDA-approved course attendee (21 CFR 108.25(f)). 4. **Inadequate product coding:** Acidified food containers lacked identifying codes specifying establishment, product, year, date, and packing period