FDA Inspection
Advanced Skin Technologies, Inc.Advanced Skin Technologies, Inc. – FDA Inspection, Sep 15, 2017
Record Details
This FDA Inspection record concerns Advanced Skin Technologies, Inc., with an inspection on September 15, 2017, issued by the Center for Veterinary Medicine, covering veterinary.
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ID · 03669d70-2a17-41d6-85c6-a86f46396200
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1025342
- FDA center
- Animal Drugs & Feeds
- Project area
- Monitoring of Marketed Animal Drugs, Feed, and Devices
- Outcome
- Form 483 issued
FDA Citations
3- 21 CFR 211.113(a)Procedures for non-sterile drug products
- 21 CFR 211.192Investigations of discrepancies, failures
- 21 CFR 211.166(a)Lack of written stability program
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Other FDA inspections of Advanced Skin Technologies, Inc.
5| Date | Classification | Office | Project area |
|---|---|---|---|
| May 2, 2014 | NAI | Center for Food Safety and Applied Nutrition | Colors and Cosmetics Technology |
| October 11, 2011 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| March 16, 2011 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| February 16, 2011 | NAI | Center for Veterinary Medicine | Monitoring of Marketed Animal Drugs, Feed, and Devices |
| January 7, 2010 | OAI | Center for Veterinary Medicine | Monitoring of Marketed Animal Drugs, Feed, and Devices |
Other documents for Advanced Skin Technologies, Inc.
- FDA Inspection 877793 - 2014-05-02
- FDA Inspection 749192 - 2011-10-11
- FDA Inspection 713920 - 2011-03-16
- FDA Inspection 710382 - 2011-02-16
- FDA Inspection 635548 - 2010-01-07
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