Glaxo Operations UK Limited, Ware, United Kingdom – FDA Inspections

Inspection records and compliance data for Glaxo Operations UK Limited in Ware. 8 FDA inspections on record, 1 Form 483, last inspected December 06, 2024.

Company Profile

This profile covers Glaxo Operations UK Limited based in Ware, United Kingdom.

FDA Inspection History

FDA inspections: 8
OAI: 0
VAI: 4
NAI: 3
Unclassified: 1
Form 483s: 1
Warning letters: 0

First inspected July 21, 2009. Last inspected December 6, 2024.

Most cited issue areas

Complaint Handling Procedure1 inspection
Control procedures to monitor and validate performance1 inspection
Procedures for non-sterile drug products1 inspection

FDA inspections (8)

Date	Result	FDA center(s)	Insp. #
December 6, 2024	Not classified	Human Drugs	1267917
September 6, 2019	VAI	Human Drugs · Drug Quality Assurance	1102175
January 25, 2019	VAI	Human Drugs · Drug Quality Assurance	1099616
July 10, 2015	NAI	Human Drugs · Drug Quality Assurance	935343
September 12, 2014	NAI	Human Drugs · Drug Quality Assurance	898406
April 25, 2013	VAI	Human Drugs · Drug Quality Assurance	827578
March 30, 2012	VAI	Human Drugs · Drug Quality Assurance	783812
July 21, 2009	NAI	Human Drugs · Drug Quality Assurance	621577

FDA documents

Form 483s (1)

Form 483s · September 6, 2019

Other regulators (1)

UK MHRA · 8 inspections · last March 10, 2026

People (1)

Erika V. Butler

Person

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