FDA Inspection 567091 — Biomat USA Inc
The FDA completed an inspection of Biomat USA Inc on Mar 6, 2009 in Clearwater, FL. 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). 4 citations were issued during this inspection. Product area: Biologics.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Mar 6, 2009
- Fiscal Year
- 2009
- Product Type
- Biologics
- Project Area
- Blood and Blood Products
- Location
- Clearwater, FL (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 31 | 21 CFR 606.20(b) | Qualifications of responsible personnel |
| 3245 | 21 CFR 640.61 | Explanation of hazards |
| 362 | 21 CFR 606.121(e)(5) | Required labeling information - Source Plasma |
| 95 | 21 CFR 606.100(b)(16) | Labeling procedures to avoid labeling mix-ups |