FDA Inspection
Pfizer Asia Manufacturing Pte Ltd.Pfizer Asia Manufacturing Pte Ltd. – FDA Inspection, Oct 27, 2021
Record Details
This FDA Inspection record concerns Pfizer Asia Manufacturing Pte Ltd., with an inspection on October 27, 2021, issued by the Center for Drug Evaluation and Research, covering drugs.
- Inspection Date
- October 27, 2021
- Product Type
- Drugs
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ID · 6ecd8529-b24e-4f45-a1dc-6dbc45d8e796
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1156359
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
2- 21 CFR 211.22(d)Procedures not in writing, fully followed
- 21 CFR 211.42(c)Defined areas of adequate size for operations
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Other FDA inspections of Pfizer Asia Manufacturing Pte Ltd.
5| Date | Classification | Office | Project area |
|---|---|---|---|
| March 15, 2019 | Not classified | Office of Inspections and Investigations | |
| March 24, 2017 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| December 3, 2015 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| March 1, 2013 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| March 19, 2009 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
Other documents for Pfizer Asia Manufacturing Pte Ltd.
- FDA Inspection 1085293 - 2019-03-15
- FDA Inspection 1009110 - 2017-03-24
- FDA Inspection 955761 - 2015-12-03
- FDA Inspection 825350 - 2013-03-01
- FDA Inspection 580783 - 2009-03-19
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