FDA Inspection
Glaxo Operations U.K. Ltd.Glaxo Operations U.K. Ltd. – FDA Inspection, Sep 17, 2019
Record Details
This FDA Inspection record concerns Glaxo Operations U.K. Ltd., with an inspection on September 17, 2019, issued by the Office of Inspections and Investigations, covering human drugs.
- People
- Kumar G. Janoria (Issuing Officer)
- Maya M. Davis (FDA Associated Person)
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ID · 8391bdd5-8330-4bf7-97ff-df96b7424ec8
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1107134
- FDA center
- Human Drugs
- Project area
- New Drug Evaluation
- Outcome
- Form 483 issued
FDA Citations
9- 21 CFR 211.100(a)Absence of Written Procedures
- 21 CFR 211.165(e)Test methods
- 21 CFR 211.186(b)(7)Theoretical yield statement including percentages
- 21 CFR 211.188Prepared for each batch, include complete information
- 21 CFR 211.192Investigations of discrepancies, failures
- 21 CFR 211.22(d)Procedures not in writing, fully followed
- 21 CFR 211.25(a)Training--operations, GMPs, written procedures
- 21 CFR 211.42(c)Defined areas of adequate size for operations
- 21 CFR 211.67(a)Cleaning / Sanitizing / Maintenance
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Other FDA inspections of Glaxo Operations U.K. Ltd.
10| Date | Classification | Office | Project area |
|---|---|---|---|
| March 16, 2023 | Not classified | Office of Inspections and Investigations | |
| February 10, 2023 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| July 4, 2017 | Not classified | Office of Inspections and Investigations | |
| June 2, 2017 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| June 23, 2015 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
Other documents for Glaxo Operations U.K. Ltd.
- FDA Inspection 1211398 - 2023-03-16
- FDA Inspection 1209851 - 2023-02-10
- FDA Inspection 1016930 - 2017-07-04
- FDA Inspection 1014765 - 2017-06-02
- FDA Inspection 933676 - 2015-06-23
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