FDA Inspection 995169 — Tongling Jieya Biologic Technology Stock Co., Ltd.
The FDA completed an inspection of Tongling Jieya Biologic Technology Stock Co., Ltd. on December 9, 2016 in Tongling. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 3 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- December 9, 2016
- Fiscal Year
- 2017
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Tongling (China)
Citations
| ID | CFR | Description |
|---|---|---|
| 2401 | 21 CFR 211.194(a)(4) | Complete Test Data |
| 3602 | 21 CFR 211.160(a) | Deviations from laboratory control requirements |
| 4406 | 21 CFR 211.194(a)(2) | Suitability of testing methods verified |