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FDA Inspection
•AFAM Concept, Inc.•February 12, 2010

AFAM Concept, Inc. – FDA Inspection, Feb 12, 2010

Record Details

This FDA Inspection record concerns AFAM Concept, Inc., with an inspection on February 12, 2010, issued by the Center for Food Safety and Applied Nutrition, covering food/cosmetics.

Company
AFAM Concept, Inc.
Inspection Date
February 12, 2010
Product Type
Food/cosmetics
Office
Center for Food Safety and Applied Nutrition
View Company Profile

ID · bdc84678-c09e-4a4c-b044-0f3f98bf1e14

Inspection Facts

Voluntary Action Indicated (VAI)

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

Inspection number
646568
FDA center
Foods & Cosmetics
Project area
Colors and Cosmetics Technology

FDA Citations

15
  1. 21 CFR 211.188(b)(8)Labeling control records including specimens or copies
  2. 21 CFR 211.188(b)(4)Weights and measures of components used
  3. 21 CFR 211.84(d)(2)Component written specification
  4. 21 CFR 211.160(b)(3)Acceptance of drug products
  5. 21 CFR 211.186(b)(8)Description of containers, labels, et. al.
  6. 21 CFR 211.198(a)Complaint Handling Procedure
  7. 21 CFR 211.142Written warehousing procedures established/followed
  8. 21 CFR 211.186(a)Written procedures followed
  9. 21 CFR 211.122(c)Records fail to include
  10. 21 CFR 211.188(b)(9)Container/Closure Description

Showing 10 of 15 citations.

Full citation text and observation details available on the Dashboard.

Other FDA inspections of AFAM Concept, Inc.

3
DateClassificationOfficeProject area
March 4, 2021NAICenter for Drug Evaluation and ResearchDrug Quality Assurance
April 17, 2014VAICenter for Food Safety and Applied NutritionColors and Cosmetics Technology
December 11, 2008VAICenter for Food Safety and Applied NutritionColors and Cosmetics Technology
Other documents for AFAM Concept, Inc.
  • FDA Inspection 1140369 - 2021-03-04
  • FDA Inspection 871745 - 2014-04-17
  • FDA Inspection 547903 - 2008-12-11

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