FDA WARNING_LETTER - Golden Bridge Gourmet, Inc., DBA Golden Bridge Enterprises - July 18, 2022
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On January 3, 2023, the FDA issued a Warning Letter to Golden Bridge Gourmet, Inc. DBA Golden Bridge Enterprises following a Foreign Supplier Verification Program (FSVP) inspection on July 18, 2022 (and a previous inspection on February 13, 2019). The inspection revealed significant violations of section 805 of the FD&C Act and 21 CFR part 1, subpart L, concerning imported foods.
Key violations include: 1. **Failure to develop an FSVP:** The firm did not develop, maintain, and follow an FSVP for imported foods, as required by 21 CFR 1.502(a). 2. **Inadequate foreign supplier approval:** The firm failed to approve foreign suppliers based on a comprehensive evaluation of their performance and food risk, specifically neglecting to consider the supplier's procedures, processes, practices related to food safety, and compliance with applicable FDA food safety regulations (e.g., 21 CFR Part 117 Preventive Control Requirements) for products like Le Sfogliette Dorate Biscuits, Black Olives, and Unseasoned Black Olive Paste, as required by 21 CFR 1.505(a). 3. **Failure to perform foreign supplier verification activities:** The firm did not establish written procedures for verification activities (21 CFR 1.506(b
- Inspection Date
- July 18, 2022
- Product Type
- Food
ID · 324a1d6a-6cb7-402b-877f-12b0a2a77e0f
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