FDA Inspection
AstraZeneca Pharmaceuticals LPAstraZeneca Pharmaceuticals LP – FDA Inspection, Jan 30, 2018
Record Details
This FDA Inspection record concerns AstraZeneca Pharmaceuticals LP, with an inspection on January 30, 2018, issued by the Center for Drug Evaluation and Research, covering drugs.
View Company Profile
ID · c9e65f66-82de-438f-8f3b-d9031f8e55ba
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1039113
- FDA center
- Human Drugs
- Project area
- Postmarket Surv. and Epidemiology
- Outcome
- Form 483 issued
FDA Citations
1- 21 CFR 314.80(c)(1)(i)Late submission of 15-day report
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 | |
| May 31, 2024 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| January 22, 2024 | NAI | Center for Drug Evaluation and Research | Bioresearch Monitoring |
| July 18, 2023 | 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 1238346 - 2024-05-31
- FDA Inspection 1230136 - 2024-01-22
- FDA Inspection 1211604 - 2023-07-18
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.