FDA Inspection
Gilead Sciences Ireland UCGilead Sciences Ireland UC – FDA Inspection, Nov 10, 2017
Record Details
This FDA Inspection record concerns Gilead Sciences Ireland UC, with an inspection on November 10, 2017, issued by the Center for Drug Evaluation and Research, covering drugs.
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ID · 37e579f6-86ed-4ed2-bcde-720686ef3176
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1031710
- FDA center
- Human Drugs
- Project area
- New Drug Evaluation
- Outcome
- Form 483 issued
FDA Citations
1- 21 CFR 211.122(e)Destruction of obsolete labeling
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Other FDA inspections of Gilead Sciences Ireland UC
5| Date | Classification | Office | Project area |
|---|---|---|---|
| September 9, 2023 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| April 13, 2018 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| February 26, 2016 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| August 8, 2013 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| June 12, 2009 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
Other documents for Gilead Sciences Ireland UC
- FDA Inspection 1266783 - 2023-09-09
- FDA Inspection 1123087 - 2018-04-13
- FDA Inspection 962998 - 2016-02-26
- FDA Inspection 854681 - 2013-08-08
- FDA Inspection 594563 - 2009-06-12
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