FDA Inspection
Quagen Pharmaceuticals LLCQuagen Pharmaceuticals LLC – FDA Inspection, Nov 8, 2023
Record Details
This FDA Inspection record concerns Quagen Pharmaceuticals LLC, with an inspection on November 8, 2023, issued by the Center for Drug Evaluation and Research, covering drugs.
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ID · 22c15808-cc5c-4265-a46e-d62b2a6a69ea
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1222389
- FDA center
- Human Drugs
- Project area
- Bioresearch Monitoring
- Outcome
- Form 483 issued
FDA Citations
2- 21 CFR 314.80(b)Failure to develop written procedures
- 21 CFR 314.80(b)Failure to develop written procedures
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Quagen Pharmaceuticals LLC
3| Date | Classification | Office | Project area |
|---|---|---|---|
| May 19, 2026 | Not classified | New Jersey District Office | |
| December 19, 2022 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| March 15, 2019 | Not classified | New Jersey District Office |
Other documents for Quagen Pharmaceuticals LLC
- FDA Inspection 1322648 - 2026-05-19
- FDA Inspection 1194335 - 2022-12-19
- FDA Inspection 1085743 - 2019-03-15
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