FDA Inspection
Hysan Pharmaceutical Co., Ltd.Hysan Pharmaceutical Co., Ltd. – FDA Inspection, Sep 10, 2015
Record Details
This FDA Inspection record concerns Hysan Pharmaceutical Co., Ltd., with an inspection on September 10, 2015, issued by the Center for Drug Evaluation and Research, covering drugs.
- Inspection Date
- September 10, 2015
- Product Type
- Drugs
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ID · b393d2c4-d54f-4753-80e6-1523d258448f
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 941851
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
12- 21 CFR 211.188(b)(8)Labeling control records including specimens or copies
- 21 CFR 211.137(a)Expiration date lacking
- 21 CFR 211.25(a)GMP Training Frequency
- 21 CFR 211.160(b)(1)Incoming lots - conformance to written specs-
- 21 CFR 211.194(a)Complete test data included in records
- 21 CFR 211.194(d)Laboratory equipment calibration records
- 21 CFR 211.84(d)(2)Reports of Analysis (Components)
- 21 CFR 211.84(d)(1)Identity Testing of Each Component
- 21 CFR 211.166(a)Lack of written stability program
- 21 CFR 211.160(b)(4)Instruments, apparatus, et. al. not meeting specs
Showing 10 of 12 citations.
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Other FDA inspections of Hysan Pharmaceutical Co., Ltd.
3| Date | Classification | Office | Project area |
|---|---|---|---|
| June 12, 2025 | VAI | Office of Inspections and Investigations | Drug Quality Assurance |
| March 29, 2018 | 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 1274837 - 2025-06-12
- FDA Inspection 1047429 - 2018-03-29
- FDA Inspection 822258 - 2012-10-11
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