Warning letterPosted June 10, 2025
FDA warning letter to Gongora USA Corp
Foreign Supplier Verification Program (FSVP)
FDA posted a warning letter to Gongora USA Corp on June 10, 2025; the letter is dated January 2, 2025. Subject: Foreign Supplier Verification Program (FSVP). Issuing office: Division of Southwest Imports.
On the record
- Company
- Gongora USA Corp
- Subject
- Foreign Supplier Verification Program (FSVP)
- Issuing office
- Division of Southwest Imports
- Letter dated
- 2025-01-02
- Posted by FDA
- 2025-06-10
- Source
- FDA warning letters ↗
CFR cited
The record cites 2 sections of 21 CFR Parts 1 and 112.
The full record
An account shows the violations FDA described and each CFR section it cited.
What a warning letter is
A warning letter is FDA's notice to a company that it found significant violations of federal requirements. FDA asks for a written response, normally within 15 working days. The letter is advisory: it states the agency's position and is not a final agency action.
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