FDA Inspection
GlaxoWellcome ProductionGlaxoWellcome Production – FDA Inspection, Mar 3, 2017
Record Details
This FDA Inspection record concerns GlaxoWellcome Production, with an inspection on March 3, 2017, issued by the Center for Drug Evaluation and Research, covering drugs.
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ID · b673f0a0-aaff-450b-b76a-74f9a1411f35
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1005796
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
- Outcome
- Form 483 issued
FDA Citations
1- 21 CFR 314.81(b)(1)(ii)Failure to meet specifications
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Other FDA inspections of GlaxoWellcome Production
4| Date | Classification | Office | Project area |
|---|---|---|---|
| April 8, 2022 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| April 11, 2014 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| February 27, 2012 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| March 19, 2009 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
Other documents for GlaxoWellcome Production
- FDA Inspection 1242271 - 2022-04-08
- FDA Inspection 886660 - 2014-04-11
- FDA Inspection 772742 - 2012-02-27
- FDA Inspection 572931 - 2009-03-19
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