FDA Inspection
Cosmedx Science Inc.Cosmedx Science Inc. – FDA Inspection, Aug 26, 2015
Record Details
This FDA Inspection record concerns Cosmedx Science Inc., with an inspection on August 26, 2015, issued by the Center for Drug Evaluation and Research, covering drugs.
- Company
- Cosmedx Science Inc.
- Inspection Date
- August 26, 2015
- Product Type
- Drugs
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ID · 2cc0d9c2-a6d4-47a9-ae4a-1ff89e80ce44
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 941229
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
4- 21 CFR 211.142(b)Storage under appropriate conditions
- 21 CFR 211.192Investigations of discrepancies, failures
- 21 CFR 211.22(d)Procedures not in writing, fully followed
- 21 CFR 211.111Establishment of time limitations
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Other FDA inspections of Cosmedx Science Inc.
4| Date | Classification | Office | Project area |
|---|---|---|---|
| February 4, 2013 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| March 13, 2012 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| April 5, 2011 | OAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| December 16, 2008 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
Other documents for Cosmedx Science Inc.
- FDA Inspection 819176 - 2013-02-04
- FDA Inspection 771619 - 2012-03-13
- FDA Inspection 712022 - 2011-04-05
- FDA Inspection 552271 - 2008-12-16
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