Glaxo Operations UK Ltd — FDA Facility Profile
Glaxo Operations UK Ltd is an FDA-registered facility (FEI 3003262904) located in Hertfordshire, GB. Registered operations: ANALYSIS; API MANUFACTURE; LABEL; MANUFACTURE; PACK; PARTICLE SIZE REDUCTION. RegDataLab tracks 8 FDA inspections at this facility.
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What FDA found at this site
- Latest inspection
- Dec 6, 2024: Voluntary Action Indicated (VAI)
- Inspections on record
- 8 (5 VAI, 3 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
- Import refusals
- 10 or more
Inspections and what FDA cited
| Date | Result | What FDA cited |
|---|---|---|
| Dec 6, 2024 | Voluntary Action Indicated (VAI) | No citations listed |
| Sep 6, 2019 | Voluntary Action Indicated (VAI) | Procedures for non-sterile drug products (21 CFR 211.113(a)) |
| Jan 25, 2019 | Voluntary Action Indicated (VAI) | No citations listed |
| Jul 10, 2015 | No Action Indicated (NAI) | No citations listed |
| Sep 12, 2014 | No Action Indicated (NAI) | No citations listed |
| Apr 25, 2013 | Voluntary Action Indicated (VAI) | No citations listed |
| Mar 30, 2012 | Voluntary Action Indicated (VAI) | Complaint Handling Procedure (21 CFR 211.198(a)) Control procedures to monitor and validate performance (21 CFR 211.110(a)) Scientifically sound laboratory controls (21 CFR 211.160(b)) Storage under appropriate conditions (21 CFR 211.142(b)) |
| Jul 21, 2009 | No Action Indicated (NAI) | No citations listed |
Facility details
- Company
- Glaxo Operations UK Limited
- Location
- Hertfordshire (GB)
- Registration Expires
- Dec 31, 2026
- Operations
- ANALYSIS; API MANUFACTURE; LABEL; MANUFACTURE; PACK; PARTICLE SIZE REDUCTION
- Source
- decrs