FDA Inspection
Adare Pharmaceuticals SrlAdare Pharmaceuticals Srl – FDA Inspection, May 30, 2014
Record Details
This FDA Inspection record concerns Adare Pharmaceuticals Srl, with an inspection on May 30, 2014, issued by the Center for Drug Evaluation and Research, covering drugs.
- Company
- Adare Pharmaceuticals Srl
- Inspection Date
- May 30, 2014
- Product Type
- Drugs
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ID · 6410e002-4f7f-4564-b426-153943490d32
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 883317
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
4- 21 CFR 211.68(b)Computer control of master formula records
- 21 CFR 211.160(b)Scientifically sound laboratory controls
- 21 CFR 211.22(d)Procedures not in writing, fully followed
- 21 CFR 211.67(b)Written procedures not established/followed
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Other FDA inspections of Adare Pharmaceuticals Srl
5| Date | Classification | Office | Project area |
|---|---|---|---|
| October 28, 2022 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| April 13, 2018 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| February 24, 2017 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| July 19, 2012 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| October 9, 2009 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
Other documents for Adare Pharmaceuticals Srl
- FDA Inspection 1204801 - 2022-10-28
- FDA Inspection 1098299 - 2018-04-13
- FDA Inspection 1006241 - 2017-02-24
- FDA Inspection 793805 - 2012-07-19
- FDA Inspection 622477 - 2009-10-09
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