FDA Inspection 1264478 — Bio Protech Yantai Inc.
The FDA completed an inspection of Bio Protech Yantai Inc. on March 13, 2025 in Yantai. The inspection was classified OAI (Official Action Indicated — objectionable conditions were found and regulatory action is recommended). 5 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- March 13, 2025
- Fiscal Year
- 2025
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Yantai (China)
Citations
| ID | CFR | Description |
|---|---|---|
| 14713 | 21 CFR 820.198(a) | Lack of or inadequate complaint procedures |
| 3118 | 21 CFR 820.75(a) | Documentation |
| 3130 | 21 CFR 820.100(a) | Lack of or inadequate procedures |
| 3266 | 21 CFR 820.86 | Acceptance status |
| 541 | 21 CFR 820.70(c) | Environmental control Lack of or inadequate procedures |