FDA Inspection
AstraZeneca LPAstraZeneca LP – FDA Inspection, May 17, 2010
Record Details
This FDA Inspection record concerns AstraZeneca LP, with an inspection on May 17, 2010, issued by the Center for Drug Evaluation and Research, covering drugs.
- Company
- AstraZeneca LP
- Inspection Date
- May 17, 2010
- Product Type
- Drugs
View Company Profile
ID · 37abc164-d2fe-4027-acf1-c427d6bfa644
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 662811
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
8- 21 CFR 211.110(a)Control procedures to monitor and validate performance
- 21 CFR 211.84(d)(6)Microbiological Contamination Exam
- 21 CFR 211.65(a)Equipment construction - reactive surfaces
- 21 CFR 211.160(b)Scientifically sound laboratory controls
- 21 CFR 211.113(b)Procedures for sterile drug products
- 21 CFR 211.84(b)Representative Samples
- 21 CFR 211.42(c)Defined areas of adequate size for operations
- 21 CFR 211.192Investigations of discrepancies, failures
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Other FDA inspections of AstraZeneca LP
4| Date | Classification | Office | Project area |
|---|---|---|---|
| April 27, 2016 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| July 23, 2014 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| June 14, 2012 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| April 27, 2011 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
Other documents for AstraZeneca LP
- FDA Inspection 979534 - 2016-04-27
- FDA Inspection 888632 - 2014-07-23
- FDA Inspection 786512 - 2012-06-14
- FDA Inspection 722306 - 2011-04-27
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