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FDA Inspection
•Skin Biology Inc•April 11, 2013

Skin 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 Food Safety and Applied Nutrition, covering food/cosmetics.

Company
Skin Biology Inc
Inspection Date
April 11, 2013
Product Type
Food/cosmetics
Office
Center for Food Safety and Applied Nutrition
View Company Profile

ID · bb60b221-0d3f-40f8-9b01-6eb0f00bae1b

Inspection Facts

Voluntary Action Indicated (VAI)

Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.

Inspection number
830932
FDA center
Foods & Cosmetics
Project area
Colors and Cosmetics Technology

FDA Citations

7
  1. 21 CFR 211.188Prepared for each batch, include complete information
  2. 21 CFR 211.25(a)Training--operations, GMPs, written procedures
  3. 21 CFR 211.67(c)Cleaning/maintenance records not kept
  4. 21 CFR 211.68(a)Written calibration / inspection records not kept
  5. 21 CFR 211.100(a)Absence of Written Procedures
  6. 21 CFR 211.56(b)Written sanitation procedures lacking
  7. 21 CFR 211.22(a)Lack of quality control unit

Full citation text and observation details available on the Dashboard.

Other FDA inspections of Skin Biology Inc

6
DateClassificationOfficeProject area
February 10, 2020NAICenter for Food Safety and Applied NutritionColors and Cosmetics Technology
February 10, 2020NAICenter for Food Safety and Applied NutritionColors and Cosmetics Technology
March 12, 2015VAICenter for Food Safety and Applied NutritionColors and Cosmetics Technology
April 11, 2013VAICenter for Drug Evaluation and ResearchUnapproved and Misbranded Drugs
March 30, 2012VAICenter for Drug Evaluation and ResearchDrug Quality Assurance
View all 6 other inspections on the company page
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 830013 - 2013-04-11
  • FDA Inspection 776471 - 2012-03-30

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