# FDA WARNING_LETTER - Portland Sandwich Company - December 06, 2019

Source: https://www.globalkeysolutions.net/records/warning_letter/portland-sandwich-company/6fd9603a-7bef-4f9e-8494-bafcc7ef06fc

> FDA WARNING_LETTER for Portland Sandwich Company on December 06, 2019. Product: Food. Access full analysis and detailed observations.

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## Details

- Record Type: WARNING_LETTER
- Company Name: Portland Sandwich Company
- Inspection Date: 2019-12-06
- Product Type: Food
- Office Name: Division of Human and Animal Food Operations - West VI
- Summary: 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

## Related Officers

- [Miriam R. Burbach](https://www.globalkeysolutions.net/people/miriam-r-burbach/68959b72-6f58-4d4b-9329-5109ffe8a649)

Company: https://www.globalkeysolutions.net/companies/portland-sandwich-company/c26067a9-62f6-4fb7-926f-19fb29382fe5

Office: https://www.globalkeysolutions.net/offices/division-of-human-and-animal-food-operations-west-vi/6e5a2a08-f464-4979-a759-7b0383370822