FDA Inspection
JW Bio Co., Ltd.JW Bio Co., Ltd. – FDA Inspection, Jan 26, 2017
Record Details
This FDA Inspection record concerns JW Bio Co., Ltd., with an inspection on January 26, 2017, issued by the Center for Drug Evaluation and Research, covering drugs.
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ID · c23f74d1-bf42-4e61-bdde-125fd9c5a680
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 1004937
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
- Outcome
- Form 483 issued
FDA Citations
7- 21 CFR 211.22(a)Lack of quality control unit
- 21 CFR 211.110(a)Written in-process control procedures
- 21 CFR 211.194(d)Laboratory equipment calibration records
- 21 CFR 211.188Prepared for each batch, include complete information
- 21 CFR 211.166(a)Lack of written stability program
- 21 CFR 211.84(d)(2)Reports of Analysis (Components)
- 21 CFR 211.198(b)(2)Written record of complaint to include findings, follow-up
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