FDA Inspection
Pfizer, Inc.Pfizer, Inc. – FDA Inspection, Jul 18, 2018
Record Details
This FDA Inspection record concerns Pfizer, Inc., with an inspection on July 18, 2018, issued by the New England District Office, covering human drugs.
View Company Profile
ID · f417b94f-af0f-4ba0-8533-3b73829d7cd0
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1059198
- FDA center
- Human Drugs
- Project area
- New Drug Evaluation
- Outcome
- Form 483 issued
FDA Citations
3- 21 CFR 211.22(d)Procedures not in writing, fully followed
- 21 CFR 211.67(a)Cleaning / Sanitizing / Maintenance
- 21 CFR 211.80(a)Written Procedures Not Followed
Full citation text and observation details available on the Dashboard.
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
Document or profile
One record shows the event. A profile shows the pattern.
Buy this document for the source file and details behind this single event.
Choose full profile access to connect related records, sites, people, citations, and enforcement history in one view.