FDA Inspection
Cosmetic Creations Inc.Cosmetic Creations Inc. – FDA Inspection, Sep 3, 2010
Record Details
This FDA Inspection record concerns Cosmetic Creations Inc., with an inspection on September 3, 2010, issued by the Center for Drug Evaluation and Research, covering drugs.
- Company
- Cosmetic Creations Inc.
- Inspection Date
- September 3, 2010
- Product Type
- Drugs
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ID · e70a9be3-5434-4309-8e5b-173d8bfb4068
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 680120
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
10- 21 CFR 211.103Actual vs. theoretical yields not determined
- 21 CFR 211.110(a)Control procedures to monitor and validate performance
- 21 CFR 211.160(b)Scientifically sound laboratory controls
- 21 CFR 211.194(a)(1)Sample identification and other information
- 21 CFR 211.194(a)(2)Reference and method not stated
- 21 CFR 211.68(a)Calibration/Inspection/Checking not done
- 21 CFR 211.165(a)Testing and release for distribution
- 21 CFR 211.166(a)Lack of written stability program
- 21 CFR 211.22(d)Procedures not in writing, fully followed
- 21 CFR 211.110(a)Written in-process control procedures
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Other FDA inspections of Cosmetic Creations Inc.
2| Date | Classification | Office | Project area |
|---|---|---|---|
| April 8, 2016 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| November 14, 2008 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
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