FDA Inspection
Yung Shin Pharmaceutical Industrial (Kunshan) Co., Ltd.Yung Shin Pharmaceutical Industrial (Kunshan) Co., Ltd. – FDA Inspection, Mar 15, 2019
Record Details
This FDA Inspection record concerns Yung Shin Pharmaceutical Industrial (Kunshan) Co., Ltd., with an inspection on March 15, 2019, issued by the Center for Drug Evaluation and Research, covering drugs.
- Inspection Date
- March 15, 2019
- Product Type
- Drugs
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ID · 63bd24c8-181a-4e07-94b9-11eb6d9812f2
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1085068
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
- Outcome
- Form 483 issued
FDA Citations
2- 21 CFR 211.160(a)Deviations from laboratory control requirements
- 21 CFR 211.160(b)Scientifically sound laboratory controls
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Other FDA inspections of Yung Shin Pharmaceutical Industrial (Kunshan) Co., Ltd.
3| Date | Classification | Office | Project area |
|---|---|---|---|
| April 3, 2015 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| May 17, 2013 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| February 26, 2009 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
Other documents for Yung Shin Pharmaceutical Industrial (Kunshan) Co., Ltd.
- FDA Inspection 921598 - 2015-04-03
- FDA Inspection 832214 - 2013-05-17
- FDA Inspection 570377 - 2009-02-26
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