FDA Inspection
AstraZeneca Pharmaceuticals LPAstraZeneca Pharmaceuticals LP – FDA Inspection, Jul 22, 2022
Record Details
This FDA Inspection record concerns AstraZeneca Pharmaceuticals LP, with an inspection on July 22, 2022, issued by the Center for Biologics Evaluation and Research, covering biologics.
- Inspection Date
- July 22, 2022
- Product Type
- Biologics
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ID · dae5e2be-5942-4a41-b4a5-3f7bf88d2245
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1175133
- FDA center
- Biologics
- Project area
- Vaccines and Allergenic Products
FDA Citations
3- 21 CFR 211.63Equipment Design, Size and Location
- 21 CFR 211.192Extent of discrepancy, failure investigations
- 21 CFR 211.113(b)Procedures for sterile drug products
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Other FDA inspections of AstraZeneca Pharmaceuticals LP
8| Date | Classification | Office | Project area |
|---|---|---|---|
| June 24, 2025 | NAI | Center for Biologics Evaluation and Research | Vaccines and Allergenic Products |
| June 20, 2018 | VAI | Center for Biologics Evaluation and Research | Vaccines and Allergenic Products |
| May 20, 2015 | VAI | Center for Biologics Evaluation and Research | Vaccines and Allergenic Products |
| May 22, 2013 | VAI | Center for Biologics Evaluation and Research | Vaccines and Allergenic Products |
| May 3, 2011 | VAI | Center for Biologics Evaluation and Research | Vaccines and Allergenic Products |
Other documents for AstraZeneca Pharmaceuticals LP
- FDA Inspection 1277181 - 2025-06-24
- FDA Inspection 1060670 - 2018-06-20
- FDA Inspection 940375 - 2015-05-20
- FDA Inspection 846805 - 2013-05-22
- FDA Inspection 747381 - 2011-05-03
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