FDA Inspection
Pfizer, Inc.Pfizer, Inc. – FDA Inspection, Jun 7, 2017
Record Details
This FDA Inspection record concerns Pfizer, Inc., with an inspection on June 7, 2017, issued by the Center for Drug Evaluation and Research, covering drugs.
- People
- Christopher Janik (FDA Associated Person)
- Dien N. Nguyen (Issuing Officer)
- Nealie C. Newberger
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ID · f6b7f6c9-8550-47e9-a7cd-ecc54ff22ae0
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1013440
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
- Outcome
- Form 483 issued
FDA Citations
4- 21 CFR 211.160(a)Following/documenting laboratory controls
- 21 CFR 211.165(e)Test methods
- 21 CFR 211.192Investigations of discrepancies, failures
- 21 CFR 211.22(d)Procedures not in writing, fully followed
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Other FDA inspections of Pfizer, Inc.
25| Date | Classification | Office | Project area |
|---|---|---|---|
| October 24, 2025 | Not classified | New England District Office | |
| December 13, 2024 | VAI | New England District Office | Bioresearch Monitoring: Human Drugs |
| August 30, 2024 | Not classified | New England District Office | |
| July 19, 2024 | Not classified | New England District Office | |
| April 19, 2023 | NAI | Center for Drug Evaluation and Research | Bioresearch Monitoring |
Other documents for Pfizer, Inc.
- FDA Inspection 1284680 - 2025-10-24
- FDA Inspection 1256477 - 2024-12-13
- FDA Inspection 1249289 - 2024-08-30
- FDA Inspection 1230476 - 2024-07-19
- FDA Inspection 1204434 - 2023-04-19
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