FDA Inspection
AJENAT PHARMACEUTICALS LLCAJENAT PHARMACEUTICALS LLC – FDA Inspection, Aug 16, 2024
Record Details
This FDA Inspection record concerns AJENAT PHARMACEUTICALS LLC, with an inspection on August 16, 2024, issued by the Center for Drug Evaluation and Research, covering drugs.
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ID · 86e0a09f-9bb7-4cf0-abf3-8d05e39fb85f
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1246567
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
8- 21 CFR 211.160(b)Scientifically sound laboratory controls
- 21 CFR 211.165(b)Microbiological testing
- FD&C Act 503B(b)(2)(A)All inclusive product report, not submitted
- FD&C Act 503B(a)(10)(A)Drug product labels, fails to include
- 21 CFR 211.42(c)(10)(iii)Air Supply
- 21 CFR 211.167(c)Controlled release dosage form testing
- FDCA 503B(a)(10)(A)Drug product labels, fails to include
- FDCA 503B(b)(2)(A)All inclusive product report, not submitted
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Other FDA inspections of AJENAT PHARMACEUTICALS LLC
4| Date | Classification | Office | Project area |
|---|---|---|---|
| September 24, 2026 | Not classified | Florida District Office | Drug Quality Assurance |
| February 7, 2025 | Not classified | Florida District Office | |
| May 24, 2019 | NAI | Center for Drug Evaluation and Research | Bioresearch Monitoring |
| March 1, 2018 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
Other documents for AJENAT PHARMACEUTICALS LLC
- FDA Inspection 1337342 - 2026-09-24
- FDA Inspection 1262754 - 2025-02-07
- FDA Inspection 1093582 - 2019-05-24
- FDA Inspection 1042674 - 2018-03-01
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