FDA Inspection
AFAM Concept, Inc.AFAM Concept, Inc. – FDA Inspection, Dec 11, 2008
Record Details
This FDA Inspection record concerns AFAM Concept, Inc., with an inspection on December 11, 2008, issued by the Center for Food Safety and Applied Nutrition, covering food/cosmetics.
- Company
- AFAM Concept, Inc.
- Inspection Date
- December 11, 2008
- Product Type
- Food/cosmetics
View Company Profile
ID · de4bef65-a726-4e34-b143-9aaca55fa3df
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 547903
- FDA center
- Foods & Cosmetics
- Project area
- Colors and Cosmetics Technology
FDA Citations
25- 21 CFR 211.103Actual vs. theoretical yields not determined
- 21 CFR 211.22(b)Adequate lab facilities not available
- 21 CFR 211.192Quality control unit review of records
- 21 CFR 211.101(d)Component addition checked by 2nd person
- 21 CFR 211.25(a)Training--operations, GMPs, written procedures
- 21 CFR 211.130(e)Packaging line inspection before use
- 21 CFR 211.130(e)Packaging line inspection after use
- 21 CFR 211.160(b)Scientifically sound laboratory controls
- 21 CFR 211.160(b)(4)Establishment of calibration procedures
- 21 CFR 211.198(a)Complaint Handling Procedure
Showing 10 of 25 citations.
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Other FDA inspections of AFAM Concept, Inc.
3| Date | Classification | Office | Project area |
|---|---|---|---|
| March 4, 2021 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| April 17, 2014 | VAI | Center for Food Safety and Applied Nutrition | Colors and Cosmetics Technology |
| February 12, 2010 | VAI | Center for Food Safety and Applied Nutrition | Colors and Cosmetics Technology |
Other documents for AFAM Concept, Inc.
- FDA Inspection 1140369 - 2021-03-04
- FDA Inspection 871745 - 2014-04-17
- FDA Inspection 646568 - 2010-02-12
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