FDA Inspection
Advanced Skin Technologies, Inc.Advanced Skin Technologies, Inc. – FDA Inspection, Mar 16, 2011
Record Details
This FDA Inspection record concerns Advanced Skin Technologies, Inc., with an inspection on March 16, 2011, issued by the Center for Drug Evaluation and Research, covering drugs.
- Inspection Date
- March 16, 2011
- Product Type
- Drugs
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ID · 4298a82c-9d1b-44ee-be48-3311fbaa3cd8
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 713920
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
10- 21 CFR 211.137(a)Expiration date lacking
- 21 CFR 211.25(a)Training--operations, GMPs, written procedures
- 21 CFR 211.160(b)Scientifically sound laboratory controls
- 21 CFR 211.198(a)Procedures to be written and followed
- 21 CFR 211.67(c)Cleaning/maintenance records not kept
- 21 CFR 211.165(a)Testing and release for distribution
- 21 CFR 211.100(a)Absence of Written Procedures
- 21 CFR 211.122(a)Written procedures describing in detail
- 21 CFR 211.22(a)Lack of quality control unit
- 21 CFR 211.80(a)Procedures To Be in Writing
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Other FDA inspections of Advanced Skin Technologies, Inc.
5| Date | Classification | Office | Project area |
|---|---|---|---|
| September 15, 2017 | VAI | Center for Veterinary Medicine | Monitoring of Marketed Animal Drugs, Feed, and Devices |
| 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 |
| 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 |
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