FDA Inspection 740512 — Biomat USA, Inc.
The FDA completed an inspection of Biomat USA, Inc. on Aug 22, 2011 in Van Nuys, CA. 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). 3 citations were issued during this inspection. Product area: Biologics.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Aug 22, 2011
- Fiscal Year
- 2011
- Product Type
- Biologics
- Project Area
- Blood and Blood Products
- Location
- Van Nuys, CA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 3252 | 21 CFR 640.63(a) | Determination not made on day of collection |
| 9241 | 21 CFR 630.40(a) | Supplemental results |
| 9243 | 21 CFR 630.40(a) | Notification |