FDA Inspection
AstraZeneca Pharmaceuticals LPAstraZeneca Pharmaceuticals LP – FDA Inspection, Jun 23, 2010
Record Details
This FDA Inspection record concerns AstraZeneca Pharmaceuticals LP, with an inspection on June 23, 2010, issued by the Center for Biologics Evaluation and Research, covering biologics.
- Inspection Date
- June 23, 2010
- Product Type
- Biologics
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ID · 11493b37-191a-4fe6-9b02-a0d607b0491e
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 671182
- FDA center
- Biologics
- Project area
- Vaccines and Allergenic Products
FDA Citations
5- 21 CFR 211.198(b)(2)Complaint Investigation/Follow-Up Findings
- 21 CFR 211.113(b)Procedures for sterile drug products
- 21 CFR 211.170(b)Annual visual exams of drug products
- 21 CFR 211.22(d)Procedures not in writing, fully followed
- 21 CFR 211.192Written record of investigation incomplete
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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 |
| July 22, 2022 | VAI | 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 |
Other documents for AstraZeneca Pharmaceuticals LP
- FDA Inspection 1277181 - 2025-06-24
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- FDA Inspection 1060670 - 2018-06-20
- FDA Inspection 940375 - 2015-05-20
- FDA Inspection 846805 - 2013-05-22
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