FDA Inspection 1046965 — Jianerkang Medical Co., Ltd
The FDA completed an inspection of Jianerkang Medical Co., Ltd on March 9, 2018 in Changzhou. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 2 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- March 9, 2018
- Fiscal Year
- 2018
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Changzhou (China)
Citations
| ID | CFR | Description |
|---|---|---|
| 1213 | 21 CFR 211.67(a) | Cleaning / Sanitizing / Maintenance |
| 3557 | 21 CFR 211.52 | Washing and toilet facilities are deficient |