FDA Inspection 704336 — Bio Protech, Inc.
The FDA completed an inspection of Bio Protech, Inc. on Dec 9, 2010 in Wonju-Si. 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: Devices.
Inspection details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Dec 9, 2010
- Fiscal Year
- 2011
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Wonju-Si (Korea (the Republic of))
Citations
| ID | CFR | Description |
|---|---|---|
| 14710 | 21 CFR 820.150 | Lack of or inadequate procedures for storage. |
| 3109 | 21 CFR 820.70(d) | Personnel requirements, Lack of or inadequate requirements |
| 3117 | 21 CFR 820.70(i) | Software validation for automated processes |
| 3125 | 21 CFR 820.80(d) | Lack of or inadequate final acceptance procedures |
| 3263 | 21 CFR 820.250(b) | Sampling plans |
| 3282 | 21 CFR 820.90(a) | Nonconforming product, Lack of or inadequate procedures |