Allergan Sales LLC — FDA Facility Profile
Allergan Sales LLC is an FDA-inspected facility (FEI 1523957) located in Cincinnati, OH, US. RegDataLab tracks 8 FDA inspections at this facility.
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What FDA found at this site
- Latest inspection
- Jun 24, 2021: Voluntary Action Indicated (VAI)
- Inspections on record
- 8 (6 VAI, 2 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
Inspections and what FDA cited
| Date | Result | What FDA cited |
|---|---|---|
| Jun 24, 2021 | Voluntary Action Indicated (VAI) | No citations listed |
| Jul 29, 2019 | Voluntary Action Indicated (VAI) | Retest of approved components/containers/closures (21 CFR 211.87) Investigations of discrepancies, failures (21 CFR 211.192) Control procedures to monitor and validate performance (21 CFR 211.110(a)) Scientifically sound laboratory controls (21 CFR 211.160(b)) |
| May 20, 2016 | No Action Indicated (NAI) | No citations listed |
| Sep 22, 2015 | No Action Indicated (NAI) | No citations listed |
| Nov 5, 2012 | Voluntary Action Indicated (VAI) | No citations listed |
| Dec 3, 2010 | Voluntary Action Indicated (VAI) | Strict control not exercised over labeling issued (21 CFR 211.125(a)) |
| Nov 10, 2009 | Voluntary Action Indicated (VAI) | Written procedures not established/followed (21 CFR 211.67(b)) Complaint Handling Procedure (21 CFR 211.198(a)) |
| Jul 10, 2009 | Voluntary Action Indicated (VAI) | Procedures not in writing, fully followed (21 CFR 211.22(d)) Written procedures not established/followed (21 CFR 211.67(b)) Components withheld from use pending release (21 CFR 211.84(a)) Testing and release for distribution (21 CFR 211.165(a)) and 1 more |
Facility details
- Company
- Allergan Sales LLC
- Location
- Cincinnati, OH (US)
- Source
- inspections