FDA Inspection
Hyundai Bioscience Co., Ltd.Hyundai Bioscience Co., Ltd. – FDA Inspection, Jun 22, 2018
Record Details
This FDA Inspection record concerns Hyundai Bioscience Co., Ltd., with an inspection on June 22, 2018, issued by the Center for Drug Evaluation and Research, covering drugs.
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ID · e3e7ef31-d869-40e4-905d-81f59ad0726b
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 1056839
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
- Outcome
- Form 483 issued
FDA Citations
9- 21 CFR 211.56(a)Sanitation--buildings not clean, free of infestation
- 21 CFR 211.67(a)Cleaning / Sanitizing / Maintenance
- 21 CFR 211.160(b)Scientifically sound laboratory controls
- 21 CFR 211.194(a)Complete test data included in records
- 21 CFR 211.160(b)(2)In-process samples representative, identified properly
- 21 CFR 211.165(a)Testing and release for distribution
- 21 CFR 211.165(e)Test methods
- 21 CFR 211.166(a)(3)Valid stability test methods
- 21 CFR 211.180(e)(2)Items to cover on annual reviews
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