FDA WARNING_LETTER - Portland Sandwich Company - December 06, 2019

On April 3, 2020, the FDA issued a Warning Letter to Ms. Bracy following an inspection of her ready-to-eat (RTE) sandwich facility in Portland, Oregon, from December 2-6, 2019. The inspection revealed serious violations of the Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food regulation (21 CFR Part 117).

The FDA determined that the RTE products, including closed-face meat and cheese sandwiches, are adulterated under 21 U.S.C. § 342(a)(4) due to insanitary conditions. The facility failed to conduct a hazard analysis for any products, specifically neglecting to evaluate allergen cross-contact, undeclared allergens, environmental pathogens (e.g., Listeria, Salmonella), bacterial growth due to time/temperature control issues, and chemical hazards (e.g., mycotoxins).

The facility also failed to establish and implement preventive controls as required by 21 CFR 117.135(a)(1) and did not prepare a written food safety plan for any products, as mandated by 21 CFR 117.126(a)(1). Additionally, employees did not adhere to hygienic practices (e.g., changing tasks without discarding gloves/washing hands, bare-hand contact with food), and food manufacturing conditions did not minimize contamination