FDA Inspection
Pfizer Ireland Pharmaceuticals Unlimited CompanyPfizer Ireland Pharmaceuticals Unlimited Company – FDA Inspection, Nov 12, 2019
Record Details
This FDA Inspection record concerns Pfizer Ireland Pharmaceuticals Unlimited Company, with an inspection on November 12, 2019, issued by the Center for Biologics Evaluation and Research, covering biologics.
- Inspection Date
- November 12, 2019
- Product Type
- Biologics
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ID · a7806007-1834-4ae3-898b-d259dbd29443
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1109599
- FDA center
- Biologics
- Project area
- Vaccines and Allergenic Products
FDA Citations
2- 21 CFR 600.14(a)(1)Who must report - manufacturer
- 21 CFR 211.192Investigations of discrepancies, failures
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Other FDA inspections of Pfizer Ireland Pharmaceuticals Unlimited Company
12| Date | Classification | Office | Project area |
|---|---|---|---|
| December 15, 2023 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| May 11, 2023 | Not classified | Office of Inspections and Investigations | |
| January 24, 2023 | Not classified | Office of Inspections and Investigations | |
| November 9, 2018 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| September 18, 2018 | VAI | Center for Biologics Evaluation and Research | Vaccines and Allergenic Products |
Other documents for Pfizer Ireland Pharmaceuticals Unlimited Company
- FDA Inspection 1270977 - 2023-12-15
- FDA Inspection 1208210 - 2023-05-11
- FDA Inspection 1201722 - 2023-01-24
- FDA Inspection 1112255 - 2018-11-09
- FDA Inspection 1066269 - 2018-09-18
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