Shire — FDA Facility Profile
Shire is an FDA-inspected facility (FEI 3001237683) located in Chesterbrook, PA, US. RegDataLab tracks 3 FDA inspections at this facility.
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What FDA found at this site
- Latest inspection
- Dec 2, 2010: Voluntary Action Indicated (VAI)
- Inspections on record
- 3 (2 VAI, 1 NAI)
- Last OAI inspection
- None on record
- Warning letters
- None matched to this FEI. Many letters do not state an FEI: search warning letters by company name
- Recalls as the recalling firm
- 1, latest Sep 2, 2016
- Import refusals
- 1
Inspections and what FDA cited
| Date | Result | What FDA cited |
|---|---|---|
| Dec 2, 2010 | Voluntary Action Indicated (VAI) | No citations listed |
| Apr 22, 2010 | Voluntary Action Indicated (VAI) | Equipment Design, Size and Location (21 CFR 211.63) Investigations of discrepancies, failures (21 CFR 211.192) Control procedures to monitor and validate performance (21 CFR 211.110(a)) Contamination, chemical or physical change, deterioration (21 CFR 314.81(b)(1)(ii)) |
| Aug 5, 2009 | No Action Indicated (NAI) | No citations listed |
Recalls
| Date | Class | Recall | Product and reason |
|---|---|---|---|
| Sep 2, 2016 | Class III | D-0006-2017 | Vyvanse (lisdexamfetamine dimesylate) Capsules 30 mg, 100 count bottle, Rx Only… Presence of Foreign Tablets/Capsules |
Facility details
- Company
- Shire
- Location
- Chesterbrook, PA (US)
- Source
- inspections