FDA Inspection 696608 — Biomat USA Inc.
The FDA completed an inspection of Biomat USA Inc. on November 23, 2010 in Whitehall, OH. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 11 citations were issued during this inspection. Product area: Biologics.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- November 23, 2010
- Fiscal Year
- 2011
- Product Type
- Biologics
- Project Area
- Blood and Blood Products
- Location
- Whitehall, OH (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 12203 | 21 CFR 606.170(a) | Adverse Reaction- Reports of Investigations |
| 15030 | 21 CFR 606.60(b) | Equipment calibration frequency |
| 154 | 21 CFR 606.160(a)(1) | Concurrent documentation |
| 3248 | 21 CFR 640.63(a) | Determining donor suitability |
| 3258 | 21 CFR 640.63(d) | Unreliable answers |
| 333 | 21 CFR 640.64(e) | Prevention of contamination |
| 76 | 21 CFR 606.100(b) | Establish, maintain and follow manufacturing SOPs |
| 9225 | 21 CFR 606.171 | Biological product deviation report |
| 9241 | 21 CFR 630.40(a) | Supplemental results |
| 9243 | 21 CFR 630.40(a) | Notification |
| 98 | 21 CFR 606.100(c) | Thorough investigations |