FDA Inspection
AJENAT PHARMACEUTICALS LLCAJENAT PHARMACEUTICALS LLC – FDA Inspection, Mar 1, 2018
Record Details
This FDA Inspection record concerns AJENAT PHARMACEUTICALS LLC, with an inspection on March 1, 2018, issued by the Center for Drug Evaluation and Research, covering drugs.
- People
- Christie A. Garcia (Issuing Officer)
- Christos G. Tsingelis
- Ileana Barreto-Pettit (Issuing Officer)
View Company Profile
ID · a681b8c1-6120-4644-ae9f-f1593be5e93d
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1042674
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
- Outcome
- Form 483 issued
FDA Citations
7- 21 CFR 211.25(a)Training--operations, GMPs, written procedures
- 21 CFR 211.160(a)Following/documenting laboratory controls
- 21 CFR 211.160(b)Scientifically sound laboratory controls
- 21 CFR 211.100(a)Absence of Written Procedures
- 21 CFR 211.42(c)Defined areas of adequate size for operations
- 21 CFR 211.111Establishment of time limitations
- 21 CFR 211.67(b)Written procedures fail to include
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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 | |
| August 16, 2024 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| May 24, 2019 | NAI | Center for Drug Evaluation and Research | Bioresearch Monitoring |
Other documents for AJENAT PHARMACEUTICALS LLC
- FDA Inspection 1337342 - 2026-09-24
- FDA Inspection 1262754 - 2025-02-07
- FDA Inspection 1246567 - 2024-08-16
- FDA Inspection 1093582 - 2019-05-24
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