FDA Inspection 880522 — Jianerkang Medical Co., Ltd
The FDA completed an inspection of Jianerkang Medical Co., Ltd on Apr 2, 2014 in Changzhou. 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). 6 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Apr 2, 2014
- Fiscal Year
- 2014
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Changzhou (China)
Citations
| ID | CFR | Description |
|---|---|---|
| 1213 | 21 CFR 211.67(a) | Cleaning / Sanitizing / Maintenance |
| 2031 | 21 CFR 211.194(a) | Complete test data included in records |
| 3111 | 21 CFR 820.70(f) | Buildings |
| 3565 | 21 CFR 211.58 | Buildings not maintained in good state of repair |
| 3603 | 21 CFR 211.160(b) | Scientifically sound laboratory controls |
| 537 | 21 CFR 820.70(a) | Production processes |