FDA Inspection
Hysan Pharmaceutical Co., Ltd.Hysan Pharmaceutical Co., Ltd. – FDA Inspection, Jun 12, 2025
Record Details
This FDA Inspection record concerns Hysan Pharmaceutical Co., Ltd., with an inspection on June 12, 2025, issued by the Office of Inspections and Investigations, covering human drugs.
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ID · 24fb6aa1-34d3-49fe-90bf-23c0c6ba1733
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1274837
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
- Outcome
- Form 483 issued
FDA Citations
4- 21 CFR 211.84(d)(2)Establish reliability of supplier"s C of A
- 21 CFR 211.160(b)(4)Calibration - at intervals, written program, remedial action
- 21 CFR 211.186(a)Master production and control records, batch uniformity
- 21 CFR 211.84(d)(2)Establish reliability of supplier's C of A
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Other FDA inspections of Hysan Pharmaceutical Co., Ltd.
3| Date | Classification | Office | Project area |
|---|---|---|---|
| March 29, 2018 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| September 10, 2015 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| October 11, 2012 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
Other documents for Hysan Pharmaceutical Co., Ltd.
- FDA Inspection 1047429 - 2018-03-29
- FDA Inspection 941851 - 2015-09-10
- FDA Inspection 822258 - 2012-10-11
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