Warning letterPosted July 29, 2025
FDA warning letter to Macsen Drugs
CGMP/Finished Pharmaceuticals/Adulterated
FDA posted a warning letter to Macsen Drugs on July 29, 2025; the letter is dated March 5, 2025. Subject: CGMP/Finished Pharmaceuticals/Adulterated. Issuing office: Center for Drug Evaluation and Research (CDER).
On the record
- Company
- Macsen Drugs
- Subject
- CGMP/Finished Pharmaceuticals/Adulterated
- Issuing office
- Center for Drug Evaluation and Research (CDER)
- Letter dated
- 2025-03-05
- Posted by FDA
- 2025-07-29
- Source
- FDA warning letters ↗
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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