FDA Inspection 937657 — Xiantao Tongda Non-woven Products Co., Ltd.
The FDA completed an inspection of Xiantao Tongda Non-woven Products Co., Ltd. on July 25, 2015 in Huanggang. The inspection was classified OAI (Official Action Indicated — objectionable conditions were found and regulatory action is recommended). 7 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- July 25, 2015
- Fiscal Year
- 2015
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Huanggang (China)
Citations
| ID | CFR | Description |
|---|---|---|
| 3108 | 21 CFR 820.70(e) | Contamination control, Lack of or inadequate procedures |
| 3111 | 21 CFR 820.70(f) | Buildings |
| 3113 | 21 CFR 820.70(g) | Equipment design and installation |
| 3233 | 21 CFR 820.72(a) | Calibration, Inspection, etc. Procedures Lack of or Inadequ |
| 3282 | 21 CFR 820.90(a) | Nonconforming product, Lack of or inadequate procedures |
| 3682 | 21 CFR 820.70(d) | Implementing Personnel Procedures, Health, Cleanliness. |
| 541 | 21 CFR 820.70(c) | Environmental control Lack of or inadequate procedures |