FDA Inspection
Skin Biology IncSkin Biology Inc – FDA Inspection, Apr 11, 2013
Record Details
This FDA Inspection record concerns Skin Biology Inc, with an inspection on April 11, 2013, issued by the Center for Drug Evaluation and Research, covering drugs.
- Company
- Skin Biology Inc
- Inspection Date
- April 11, 2013
- Product Type
- Drugs
View Company Profile
ID · e76e47a6-fd21-44aa-b7e8-8e25fcb7226f
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 830013
- FDA center
- Human Drugs
- Project area
- Unapproved and Misbranded Drugs
FDA Citations
12- 21 CFR 211.150(b)Recall facilitation
- 21 CFR 211.188Prepared for each batch, include complete information
- 21 CFR 211.25(a)Training--operations, GMPs, written procedures
- 21 CFR 211.125(f)Procedures Written and Followed
- 21 CFR 211.142Written warehousing procedures established/followed
- 21 CFR 211.68(a)Written calibration / inspection records not kept
- 21 CFR 211.125(a)Strict control not exercised over labeling issued
- 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
Showing 10 of 12 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 |
| March 30, 2012 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
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 776471 - 2012-03-30
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