FDA Inspection
Seoul Cosmetics Co., Ltd.Seoul Cosmetics Co., Ltd. – FDA Inspection, Feb 3, 2023
Record Details
This FDA Inspection record concerns Seoul Cosmetics Co., Ltd., with an inspection on February 3, 2023, issued by the Center for Drug Evaluation and Research, covering drugs.
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ID · f00c3a56-c062-45c1-b6ad-3c9f7b22a7a0
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 1196590
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
- Outcome
- Form 483 issued
- Enforcement
- Warning Letter
FDA Citations
12- 21 CFR 211.166(b)Adequate number of batches on stability
- 21 CFR 211.84(d)(1)Component identity verification
- 21 CFR 211.63Equipment Design, Size and Location
- 21 CFR 211.165(e)Test methods
- 21 CFR 211.110(a)Written in-process control procedures
- 21 CFR 211.100(a)Absence of Written Procedures
- 21 CFR 211.100(a)Absence of Written Procedures
- 21 CFR 211.110(a)Written in-process control procedures
- 21 CFR 211.165(e)Test methods
- 21 CFR 211.166(b)Adequate number of batches on stability
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