FDA Inspection
AstraZeneca Pharmaceuticals LPAstraZeneca Pharmaceuticals LP – FDA Inspection, Jun 16, 2009
Record Details
This FDA Inspection record concerns AstraZeneca Pharmaceuticals LP, with an inspection on June 16, 2009, issued by the Center for Biologics Evaluation and Research, covering biologics.
- Inspection Date
- June 16, 2009
- Product Type
- Biologics
View Company Profile
ID · bc5d904d-a3aa-4c0c-8f66-ceb8716194cb
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 601426
- FDA center
- Biologics
- Project area
- Vaccines and Allergenic Products
FDA Citations
5- 21 CFR 600.14(c)When to report
- 21 CFR 211.100(b)Procedure Deviations Recorded and Justified
- 21 CFR 600.14(a)(1)Who must report - manufacturer
- 21 CFR 211.110(b)In-process materials specifications
- 21 CFR 211.113(b)Procedures for sterile drug products
Full citation text and observation details available on the Dashboard.
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
- FDA Inspection 1175133 - 2022-07-22
- FDA Inspection 1060670 - 2018-06-20
- FDA Inspection 940375 - 2015-05-20
- FDA Inspection 846805 - 2013-05-22
Document or profile
One record shows the event. A profile shows the pattern.
Buy this document for the source file and details behind this single event.
Choose full profile access to connect related records, sites, people, citations, and enforcement history in one view.