Company
United StatesShire, Chesterbrook, PA – FDA Inspections
Inspection records and compliance data for Shire in Chesterbrook, Pennsylvania. 3 FDA inspections on record, last inspected December 02, 2010.
Company Profile
This profile covers Shire based in Chesterbrook, Pennsylvania, United States.
FDA Inspection History
- FDA inspections
- 3
- OAI
- 0
- VAI
- 2
- NAI
- 1
- Form 483s
- 0
- Warning letters
- 0
First inspected August 5, 2009. Last inspected December 2, 2010.
Most cited issue areas
- Contamination, chemical or physical change, deterioration1 inspection
- Control procedures to monitor and validate performance1 inspection
- Equipment Design, Size and Location1 inspection
FDA inspections (3)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| December 2, 2010 | VAI | Human Drugs · Drug Quality Assurance | 699946 |
| April 22, 2010 | VAI | Human Drugs · Drug Quality Assurance | 658286 |
| August 5, 2009 | NAI | Human Drugs · Bioresearch Monitoring | 611531 |
FDA documents
No Form 483s, Warning Letters or EIRs on record.
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Company Information
Name
Shire
FEI Number
3001237683
Address
1200 Morris Dr, Chesterbrook, Pennsylvania 19087, United States
Country
United States
ID: a4498de0-4fbf-400e-9c5d-8a5a6e6cd474