FDA Inspection
Skin Biology IncSkin Biology Inc – FDA Inspection, Mar 30, 2012
Record Details
This FDA Inspection record concerns Skin Biology Inc, with an inspection on March 30, 2012, issued by the Center for Drug Evaluation and Research, covering drugs.
- Company
- Skin Biology Inc
- Inspection Date
- March 30, 2012
- Product Type
- Drugs
View Company Profile
ID · 72e93d6d-90c5-4d9f-91a9-d16ea6dd52c0
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 776471
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
11- 21 CFR 211.188Prepared for each batch, include complete information
- 21 CFR 211.25(a)Training--operations, GMPs, written procedures
- 21 CFR 211.67(a)Cleaning / Sanitizing / Maintenance
- 21 CFR 211.160(b)Scientifically sound laboratory controls
- 21 CFR 211.67(c)Cleaning/maintenance records not kept
- 21 CFR 211.68(a)Written calibration / inspection records not kept
- 21 CFR 211.100(a)Absence of Written Procedures
- 21 CFR 211.56(b)Written sanitation procedures lacking
- 21 CFR 211.22(a)Lack of quality control unit
- 21 CFR 211.80(b)Handling and Storage to Prevent Contamination
Showing 10 of 11 citations.
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Other FDA inspections of Skin Biology Inc
6| Date | Classification | Office | Project area |
|---|---|---|---|
| February 10, 2020 | NAI | Center for Food Safety and Applied Nutrition | Colors and Cosmetics Technology |
| February 10, 2020 | NAI | Center for Food Safety and Applied Nutrition | Colors and Cosmetics Technology |
| March 12, 2015 | VAI | Center for Food Safety and Applied Nutrition | Colors and Cosmetics Technology |
| April 11, 2013 | VAI | Center for Food Safety and Applied Nutrition | Colors and Cosmetics Technology |
| April 11, 2013 | VAI | Center for Drug Evaluation and Research | Unapproved and Misbranded Drugs |
Other documents for Skin Biology Inc
- FDA Inspection 1122870 - 2020-02-10
- FDA Inspection 1122844 - 2020-02-10
- FDA Inspection 919458 - 2015-03-12
- FDA Inspection 830932 - 2013-04-11
- FDA Inspection 830013 - 2013-04-11
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