FDA Inspection 937019 — Guangzhou Haishi Biological Technology Co., Ltd.
The FDA completed an inspection of Guangzhou Haishi Biological Technology Co., Ltd. on July 24, 2015 in Guangzhou. The inspection was classified OAI (Official Action Indicated — objectionable conditions were found and regulatory action is recommended). 14 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- July 24, 2015
- Fiscal Year
- 2015
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Guangzhou (China)
Citations
| ID | CFR | Description |
|---|---|---|
| 1086 | 21 CFR 211.22(b) | Adequate lab facilities not available |
| 1168 | 21 CFR 211.34 | Consultant Records |
| 1224 | 21 CFR 211.67(b)(6) | Cleaning SOP/inspection |
| 1361 | 21 CFR 211.100(a) | Absence of Written Procedures |
| 1833 | 21 CFR 211.84(d)(1) | Identity Testing of Each Component |
| 1912 | 21 CFR 211.166(a) | Written program not followed |
| 1926 | 21 CFR 211.166(b) | Adequate number of batches on stability |
| 2011 | 21 CFR 211.188(a) | Accurate reproduction |
| 3603 | 21 CFR 211.160(b) | Scientifically sound laboratory controls |
| 3632 | 21 CFR 211.170(b) | Annual visual exams of drug products |
| 4324 | 21 CFR 211.110(b) | In-process materials specifications testing |
| 4353 | 21 CFR 211.160(b)(4) | Instruments, apparatus, et. al. not meeting specs |
| 4357 | 21 CFR 211.166(a) | Results not used for expiration dates, storage cond. |
| 4391 | 21 CFR 211.180(e)(2) | Items to cover on annual reviews |