FDA Inspection
Wyeth BioPharma Division of Wyeth Pharmaceuticals LLCWyeth BioPharma Division of Wyeth Pharmaceuticals LLC – FDA Inspection, Jan 17, 2019
Record Details
This FDA Inspection record concerns Wyeth BioPharma Division of Wyeth Pharmaceuticals LLC, with an inspection on January 17, 2019, issued by the New England District Office, covering human drugs.
- Inspection Date
- January 17, 2019
- Product Type
- Human Drugs
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ID · e986731a-745f-4e83-a2c3-c3e098bb7017
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1076789
- FDA center
- Human Drugs
- Project area
- Generic Drug Evaluation
- Outcome
- Form 483 issued
FDA Citations
2- 21 CFR 211.160(a)Following/documenting laboratory controls
- 21 CFR 211.160(a)Lab controls established, including changes
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Other FDA inspections of Wyeth BioPharma Division of Wyeth Pharmaceuticals LLC
16| Date | Classification | Office | Project area |
|---|---|---|---|
| August 6, 2026 | Not classified | New England District Office | |
| April 8, 2026 | Not classified | New England District Office | |
| February 11, 2026 | NAI | Human Cellular, Tissue, and Gene Therapies | |
| October 13, 2023 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| September 19, 2023 | VAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
Other documents for Wyeth BioPharma Division of Wyeth Pharmaceuticals LLC
- FDA Inspection 1331288 - 2026-08-06
- FDA Inspection 1311392 - 2026-04-08
- FDA Inspection 1304580 - 2026-02-11
- FDA Inspection 1223617 - 2023-10-13
- FDA Inspection 1218069 - 2023-09-19
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