FDA Inspection 1047429 — Hysan Pharmaceutical Co., Ltd.
The FDA completed an inspection of Hysan Pharmaceutical Co., Ltd. on Mar 29, 2018 in Chai Wan. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action). 7 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Mar 29, 2018
- Fiscal Year
- 2018
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Chai Wan (Hong Kong SAR)
Citations
| ID | CFR | Description |
|---|---|---|
| 1105 | 21 CFR 211.22(d) | Procedures not in writing, fully followed |
| 1215 | 21 CFR 211.67(b) | Written procedures not established/followed |
| 1495 | 21 CFR 211.122(a) | Written procedures describing in detail |
| 1914 | 21 CFR 211.166(a) | Lack of written stability program |
| 1975 | 21 CFR 211.182 | Written records kept in individual logs |
| 2007 | 21 CFR 211.186(a) | Signature and checking of records -- 2 persons |
| 2035 | 21 CFR 211.194(e) | Stability testing records not included |