FDA Inspection
Skin Prescriptives Marketing, Inc.Skin Prescriptives Marketing, Inc. – FDA Inspection, Feb 2, 2017
Record Details
This FDA Inspection record concerns Skin Prescriptives Marketing, Inc., with an inspection on February 2, 2017, issued by the Center for Drug Evaluation and Research, covering drugs.
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ID · 2fd385b5-1216-4435-aa9a-f696c655bba6
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 1001568
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
- Outcome
- Form 483 issued
FDA Citations
10- 21 CFR 211.56(a)Sanitation--buildings not clean, free of infestation
- 21 CFR 211.110(a)Control procedures to monitor and validate performance
- 21 CFR 211.84(d)(1)Component identity verification
- 21 CFR 211.25(a)Training--operations, GMPs, written procedures
- 21 CFR 211.192Extent of discrepancy, failure investigations
- 21 CFR 211.160(b)Scientifically sound laboratory controls
- 21 CFR 211.180(e)Records reviewed annually
- 21 CFR 211.165(a)Testing and release for distribution
- 21 CFR 211.166(a)Lack of written stability program
- 21 CFR 211.111Establishment of time limitations
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