FDA Inspection 685831 — BioPro, Inc.
The FDA completed an inspection of BioPro, Inc. on October 18, 2010 in Port Huron, MI. The inspection was classified NAI (No Action Indicated — no objectionable conditions were found). 4 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- No Action Indicated (NAI) (NAI)
- End Date
- October 18, 2010
- Fiscal Year
- 2011
- Product Type
- Devices
- Project Area
- Postmarket Assurance: Devices
- Location
- Port Huron, MI (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 14720 | 21 CFR 820.50(a)(3) | Acceptable supplier records, inadequate records |
| 3206 | 21 CFR 820.50(b) | Approval, inadequate purchasing data |
| 3310 | 21 CFR 820.120(b) | DHR documentation of label release {see also 820.184} |
| 3331 | 21 CFR 820.181 | DMR - not or inadequately maintained |