FDA Inspection
Yung Shin Pharmaceutical Industry Co., Ltd.Yung Shin Pharmaceutical Industry Co., Ltd. – FDA Inspection, Sep 12, 2019
Record Details
This FDA Inspection record concerns Yung Shin Pharmaceutical Industry Co., Ltd., with an inspection on September 12, 2019, issued by the Office of Inspections and Investigations, covering human drugs.
- Inspection Date
- September 12, 2019
- Product Type
- Human Drugs
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ID · 8f7f2129-fd49-4cea-8b37-e298723a8ffb
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1101829
- FDA center
- Human Drugs
- Project area
- Generic Drug Evaluation
- Outcome
- Form 483 issued
FDA Citations
2- 21 CFR 211.142(b)Storage under appropriate conditions
- 21 CFR 211.160(b)Scientifically sound laboratory controls
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Other FDA inspections of Yung Shin Pharmaceutical Industry Co., Ltd.
9| Date | Classification | Office | Project area |
|---|---|---|---|
| August 7, 2026 | Not classified | Office of Inspections and Investigations | |
| April 25, 2024 | Not classified | Office of Inspections and Investigations | |
| October 22, 2019 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| July 27, 2018 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| November 24, 2016 | Not classified | Office of Inspections and Investigations |
Other documents for Yung Shin Pharmaceutical Industry Co., Ltd.
- FDA Inspection 1338914 - 2026-08-07
- FDA Inspection 1238384 - 2024-04-25
- FDA Inspection 1111111 - 2019-10-22
- FDA Inspection 1062411 - 2018-07-27
- FDA Inspection 997026 - 2016-11-24
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