FDA Inspection
Pfizer Inc.Pfizer Inc. – FDA Inspection, Oct 15, 2012
Record Details
This FDA Inspection record concerns Pfizer Inc., with an inspection on October 15, 2012, issued by the Center for Drug Evaluation and Research, covering drugs.
- Company
- Pfizer Inc.
- Inspection Date
- October 15, 2012
- Product Type
- Drugs
View Company Profile
ID · 61c225de-bb74-46cc-b3fe-94bd27efa086
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 805292
- FDA center
- Human Drugs
- Project area
- Bioresearch Monitoring
FDA Citations
11- 21 CFR 314.80(c)Failure by applicant to report ADE
- 21 CFR 314.80(b)Failure to review ADE information
- 21 CFR 314.80(c)(1)(ii)Failure to investigate serious, unexpected events
- 21 CFR 314.80(c)(1)(ii)Submission of report follow-up
- 21 CFR 314.80(c)(2)Failure to report non-alert ADEs
- 21 CFR 314.80(c)(1)(i)Late submission of 15-day report
- 21 CFR 314.80(c)(2)Late submission of annual safety reports
- 21 CFR 314.80(c)(2)Late submission of quarterly safety reports
- 21 CFR 314.80(j)Failure to maintain records
- 21 CFR 314.80(b)Failure to develop written procedures
Showing 10 of 11 citations.
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Other FDA inspections of Pfizer Inc.
4| Date | Classification | Office | Project area |
|---|---|---|---|
| July 22, 2022 | NAI | Center for Drug Evaluation and Research | Bioresearch Monitoring |
| August 26, 2015 | VAI | Center for Drug Evaluation and Research | Bioresearch Monitoring |
| June 6, 2012 | NAI | Center for Drug Evaluation and Research | Bioresearch Monitoring |
| August 10, 2009 | OAI | Center for Drug Evaluation and Research | Bioresearch Monitoring |
Other documents for Pfizer Inc.
- FDA Inspection 1176364 - 2022-07-22
- FDA Inspection 946884 - 2015-08-26
- FDA Inspection 785976 - 2012-06-06
- FDA Inspection 606526 - 2009-08-10
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