FDA Inspection
Glaxo Wellcome Manufacturing Pte LimitedGlaxo Wellcome Manufacturing Pte Limited – FDA Inspection, Jun 1, 2018
Record Details
This FDA Inspection record concerns Glaxo Wellcome Manufacturing Pte Limited, with an inspection on June 1, 2018, issued by the Center for Drug Evaluation and Research, covering drugs.
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ID · bb19f612-9f12-414c-b441-03e54b595aa4
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1055375
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
- Outcome
- Form 483 issued
Other FDA inspections of Glaxo Wellcome Manufacturing Pte Limited
5| Date | Classification | Office | Project area |
|---|---|---|---|
| October 13, 2023 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| September 2, 2022 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| January 16, 2014 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| November 16, 2012 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| March 13, 2009 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
Other documents for Glaxo Wellcome Manufacturing Pte Limited
- FDA Inspection 1275331 - 2023-10-13
- FDA Inspection 1191253 - 2022-09-02
- FDA Inspection 865559 - 2014-01-16
- FDA Inspection 807638 - 2012-11-16
- FDA Inspection 572094 - 2009-03-13
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