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GlaxoSmithKline LLC FDA Inspection Record

FEI 1035048 · Inspections, Form 483s, warning letters and import refusals

GlaxoSmithKline LLC is an FDA-inspected facility (FEI 1035048) located in Durham, NC, US. RegDataLab tracks 11 FDA inspections at this facility.

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What FDA found at this site

Latest inspection
Aug 16, 2024: No Action Indicated (NAI)
Inspections on record
11 (11 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
2, latest Dec 12, 2023
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

Showing the 10 most recent of 11 inspections. Citations are the inspector observations FDA publishes for the inspection.

DateResultWhat FDA cited
Aug 16, 2024No Action Indicated (NAI)No citations listed
Sep 12, 2019No Action Indicated (NAI)No citations listed
Jul 15, 2016No Action Indicated (NAI)No citations listed
Apr 10, 2015No Action Indicated (NAI)No citations listed
Sep 29, 2014No Action Indicated (NAI)No citations listed
Feb 5, 2013No Action Indicated (NAI)No citations listed
Jan 31, 2013No Action Indicated (NAI)No citations listed
Dec 19, 2012No Action Indicated (NAI)No citations listed
Jul 27, 2010No Action Indicated (NAI)No citations listed
Feb 19, 2010No Action Indicated (NAI)No citations listed

Recalls

Newest first. Recalls FDA's Enforcement Report lists with this FEI as the recalling firm. The recalling firm is not always the site that made the product. Search FDA's Enforcement Report by recall number.

DateClassRecallProduct and reason
Dec 12, 2023Class IIID-0160-2024ANORO ELLIPTA (umeclidinium and vilanterol inhalation powder) 62.5 mcg/25mcg. 1 inhaler…
Failed Release Testing: Coarse Particle Mass for umeclidinium Out of Specification
Mar 29, 2005Class IIID-190-5Amoxil (trade name), Amoxicillin as Trihydrate, powder for oral suspension, 250 mg/5 mL…
Mislabeling: 250mg/5mL, 150mL bottles may be mislabeled as 250mg/5mL, 100mL bottles.

Facility details

Company
GlaxoSmithKline LLC
Location
Durham, NC (US)
Source
inspections

Import refusals

FDA data resources

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