Glaxo Operations UK Ltd — FDA Facility Profile

FEI 3002807078

Glaxo Operations UK Ltd is an FDA-registered facility (FEI 3002807078) located in Barnard Castle, GB. Registered operations: ANALYSIS; LABEL; MANUFACTURE; PACK; STERILIZE. RegDataLab tracks 8 FDA inspections at this facility.

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What FDA found at this site

Latest inspection
Feb 10, 2023: Voluntary Action Indicated (VAI)
Inspections on record
8 (7 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
Import refusals
10 or more

A Form 483 lists an inspector's observations. OAI means FDA recommends regulatory and/or administrative action. A warning letter is FDA's formal enforcement notice. No record here does not establish that a site is safe. Check this site on FDA's Data Dashboard.

Inspections and what FDA cited

Newest first. Citations are the inspector observations FDA publishes for the inspection.

DateResultWhat FDA cited
Feb 10, 2023Voluntary Action Indicated (VAI)No citations listed
Jun 2, 2017Voluntary Action Indicated (VAI)No citations listed
Jun 23, 2015Voluntary Action Indicated (VAI)No citations listed
May 9, 2013Voluntary Action Indicated (VAI)No citations listed
Sep 22, 2011Voluntary Action Indicated (VAI)No citations listed
Nov 1, 2010Voluntary Action Indicated (VAI)No citations listed
May 22, 2009No Action Indicated (NAI)No citations listed
Dec 18, 2008Voluntary Action Indicated (VAI)No citations listed

Facility details

Company
Glaxo Operations U.K. Ltd.
Location
Barnard Castle (GB)
Registration Expires
Dec 31, 2026
Operations
ANALYSIS; LABEL; MANUFACTURE; PACK; STERILIZE
Source
decrs

Sources: openFDA, FDA Data Dashboard, FDA.gov. Report a data issue: hello@regdatalab.com.