FDA WARNING_LETTER - Saratoga Potato Chips LLC - February 18, 2020

The FDA issued a Warning Letter to Mr. Margie on September 24, 2020, citing violations of the Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food regulation (21 CFR Part 117). This follows a February 18, 2020, recall of Kroger brand Sweet & Mesquite BBQ Flavored Potato Chips due to the presence of cheddar cheese flavored chips, indicating an undeclared allergen (milk).

The core violation is the failure to identify and implement preventive controls for undeclared allergens, specifically at the seasoning step. The firm admitted "human error" led to cheddar and sour cream flavored seasoning (containing milk) being used instead of barbecue seasoning. This resulted in the product being adulterated and misbranded under sections 402 and 403(w) of the Act, violating 21 CFR 117.135(a)(1) and (c)(2).

The letter emphasizes that this is not an exhaustive list of violations and the firm is responsible for full compliance. Prompt corrective action is required to avoid further regulatory action, including seizure and injunction. The firm must respond in writing within fifteen working days, detailing corrective actions, providing documentation (revised procedures, monitoring records), or explaining any delays.