FDA Inspection
Cosmetic Specialty Labs, IncCosmetic Specialty Labs, Inc – FDA Inspection, Sep 20, 2023
Record Details
This FDA Inspection record concerns Cosmetic Specialty Labs, Inc, with an inspection on September 20, 2023, covering drugs.
- Company
- Cosmetic Specialty Labs, Inc
- Inspection Date
- September 20, 2023
- Product Type
- Drugs
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ID · 93a6677d-f31b-4fc4-9389-7df385de0df8
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 1218172
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
- Outcome
- Form 483 issued
FDA Citations
13- 21 CFR 211.110(a)Control procedures to monitor and validate performance
- 21 CFR 211.160(b)Scientifically sound laboratory controls
- 21 CFR 211.165(a)Testing and release for distribution
- 21 CFR 211.166(a)Lack of written stability program
- 21 CFR 211.180(e)(1)Review of representative number of batches
- 21 CFR 211.182Written records kept in individual logs
- 21 CFR 211.184(c)Individual inventory record
- 21 CFR 211.192Investigations of discrepancies, failures
- 21 CFR 211.22(d)Procedures not in writing, fully followed
- 21 CFR 211.67(a)Cleaning / Sanitizing / Maintenance
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Other FDA inspections of Cosmetic Specialty Labs, Inc
4| Date | Classification | Office | Project area |
|---|---|---|---|
| September 11, 2015 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| November 26, 2013 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| September 22, 2010 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| September 3, 2009 | VAI | Center for Food Safety and Applied Nutrition | Foodborne Biological Hazards |
Other documents for Cosmetic Specialty Labs, Inc
- FDA Inspection 944775 - 2015-09-11
- FDA Inspection 857778 - 2013-11-26
- FDA Inspection 681800 - 2010-09-22
- FDA Inspection 616185 - 2009-09-03
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