FDA Inspection
AstraZeneca Pharmaceuticals LPAstraZeneca Pharmaceuticals LP – FDA Inspection, May 31, 2024
Record Details
This FDA Inspection record concerns AstraZeneca Pharmaceuticals LP, with an inspection on May 31, 2024, issued by the Center for Drug Evaluation and Research, covering drugs.
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ID · f4d9b1b5-b5fa-492a-8363-3e39782013b0
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1238346
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
4- 21 CFR 211.194(a)(4)Complete Test Data
- 21 CFR 211.198(a)Complaint Handling Procedure
- 21 CFR 211.192Investigations of discrepancies, failures
- 21 CFR 211.22(d)Procedures not in writing, fully followed
Full citation text and observation details available on the Dashboard.
Other FDA inspections of AstraZeneca Pharmaceuticals LP
15| Date | Classification | Office | Project area |
|---|---|---|---|
| January 14, 2026 | Not classified | Baltimore District Office | |
| October 25, 2024 | Not classified | Baltimore District Office | |
| January 22, 2024 | NAI | Center for Drug Evaluation and Research | Bioresearch Monitoring |
| July 18, 2023 | NAI | Center for Drug Evaluation and Research | Bioresearch Monitoring |
| September 30, 2021 | NAI | Center for Drug Evaluation and Research | Bioresearch Monitoring |
Other documents for AstraZeneca Pharmaceuticals LP
- FDA Inspection 1299436 - 2026-01-14
- FDA Inspection 1254239 - 2024-10-25
- FDA Inspection 1230136 - 2024-01-22
- FDA Inspection 1211604 - 2023-07-18
- FDA Inspection 1157291 - 2021-09-30
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