FDA Inspection
Glaxo Operations UK LimitedGlaxo Operations UK Limited – FDA Inspection, Mar 30, 2012
Record Details
This FDA Inspection record concerns Glaxo Operations UK Limited, with an inspection on March 30, 2012, issued by the Center for Drug Evaluation and Research, covering drugs.
- Company
- Glaxo Operations UK Limited
- Inspection Date
- March 30, 2012
- Product Type
- Drugs
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ID · ce465120-7074-4a59-98c4-5ae21862917f
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 783812
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
4- 21 CFR 211.110(a)Control procedures to monitor and validate performance
- 21 CFR 211.142(b)Storage under appropriate conditions
- 21 CFR 211.160(b)Scientifically sound laboratory controls
- 21 CFR 211.198(a)Complaint Handling Procedure
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Other FDA inspections of Glaxo Operations UK Limited
7| Date | Classification | Office | Project area |
|---|---|---|---|
| December 6, 2024 | Not classified | Office of Inspections and Investigations | |
| September 6, 2019 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| January 25, 2019 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| July 10, 2015 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| September 12, 2014 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
Other documents for Glaxo Operations UK Limited
- FDA Inspection 1267917 - 2024-12-06
- FDA Inspection 1102175 - 2019-09-06
- FDA Inspection 1099616 - 2019-01-25
- FDA Inspection 935343 - 2015-07-10
- FDA Inspection 898406 - 2014-09-12
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