FDA Inspection
AstraZeneca, PLCAstraZeneca, PLC – FDA Inspection, Mar 20, 2015
Record Details
This FDA Inspection record concerns AstraZeneca, PLC, with an inspection on March 20, 2015, issued by the Center for Drug Evaluation and Research, covering drugs.
- Company
- AstraZeneca, PLC
- Inspection Date
- March 20, 2015
- Product Type
- Drugs
View Company Profile
ID · 82c5acc8-90a6-463e-9781-292cec32db92
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 922364
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
4- 21 CFR 211.160(b)Scientifically sound laboratory controls
- 21 CFR 211.165(e)Test methods
- 21 CFR 211.22(d)Procedures not in writing, fully followed
- 21 CFR 211.192No written record of investigation
Full citation text and observation details available on the Dashboard.
Other FDA inspections of AstraZeneca, PLC
6| Date | Classification | Office | Project area |
|---|---|---|---|
| March 27, 2013 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| December 21, 2011 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| August 27, 2010 | NAI | Center for Drug Evaluation and Research | Bioresearch Monitoring |
| September 25, 2009 | NAI | Center for Drug Evaluation and Research | Bioresearch Monitoring |
| March 26, 2009 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
Other documents for AstraZeneca, PLC
- FDA Inspection 824640 - 2013-03-27
- FDA Inspection 759884 - 2011-12-21
- FDA Inspection 680556 - 2010-08-27
- FDA Inspection 616272 - 2009-09-25
- FDA Inspection 571860 - 2009-03-26
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.