FDA Inspection
Pfizer Manufacturing Belgium NVPfizer Manufacturing Belgium NV – FDA Inspection, Sep 23, 2011
Record Details
This FDA Inspection record concerns Pfizer Manufacturing Belgium NV, with an inspection on September 23, 2011, issued by the Center for Drug Evaluation and Research, covering drugs.
- Inspection Date
- September 23, 2011
- Product Type
- Drugs
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ID · fe36c940-3de8-4065-ae1c-37a28a45018a
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 750629
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
5- 21 CFR 211.94(a)Reactive/Additive/Absorptive Containers/Closures
- 21 CFR 211.46(b)Equipment for Environmental Control
- 21 CFR 211.113(b)Procedures for sterile drug products
- 21 CFR 211.192Investigations of discrepancies, failures
- 21 CFR 211.160(b)(4)Instruments, apparatus, et. al. not meeting specs
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Other FDA inspections of Pfizer Manufacturing Belgium NV
9| Date | Classification | Office | Project area |
|---|---|---|---|
| June 28, 2024 | Not classified | Office of Inspections and Investigations | |
| May 17, 2024 | Not classified | Office of Inspections and Investigations | |
| June 8, 2023 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| May 16, 2023 | Not classified | Office of Inspections and Investigations | |
| June 22, 2022 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
Other documents for Pfizer Manufacturing Belgium NV
- FDA Inspection 1240714 - 2024-06-28
- FDA Inspection 1239799 - 2024-05-17
- FDA Inspection 1208904 - 2023-06-08
- FDA Inspection 1214848 - 2023-05-16
- FDA Inspection 1203291 - 2022-06-22
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