Warning letterPosted September 22, 2026
FDA warning letter to Quantum Star LLC
Foreign Supplier Verification Program (FSVP)
FDA posted a warning letter to Quantum Star LLC on September 22, 2026; the letter is dated August 5, 2026. Subject: Foreign Supplier Verification Program (FSVP). Issuing office: Office of Inspections and Investigations.
On the record
- Company
- Quantum Star LLC
- Subject
- Foreign Supplier Verification Program (FSVP)
- Issuing office
- Office of Inspections and Investigations
- Letter dated
- 2026-08-05
- Posted by FDA
- 2026-09-22
- Source
- FDA warning letters ↗
CFR cited
The record cites 7 sections of 21 CFR Parts 1 and 507.
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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