FDA Inspection
ShireShire – FDA Inspection, Apr 22, 2010
Record Details
This FDA Inspection record concerns Shire, with an inspection on April 22, 2010, issued by the Center for Drug Evaluation and Research, covering drugs.
- Company
- Shire
- Inspection Date
- April 22, 2010
- Product Type
- Drugs
View Company Profile
ID · 44ecee10-02d5-48c0-beee-d437f8fd30ef
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 658286
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
4- 21 CFR 314.81(b)(1)(ii)Contamination, chemical or physical change, deterioration
- 21 CFR 211.110(a)Control procedures to monitor and validate performance
- 21 CFR 211.63Equipment Design, Size and Location
- 21 CFR 211.192Investigations of discrepancies, failures
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Shire
2| Date | Classification | Office | Project area |
|---|---|---|---|
| December 2, 2010 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| August 5, 2009 | NAI | Center for Drug Evaluation and Research | Bioresearch Monitoring |
Other documents for Shire
- FDA Inspection 699946 - 2010-12-02
- FDA Inspection 611531 - 2009-08-05
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.