FDA Inspection 820529 — Biomat USA Inc.
The FDA completed an inspection of Biomat USA Inc. on February 21, 2013 in Elgin, IL. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 5 citations were issued during this inspection. Product area: Biologics.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- February 21, 2013
- Fiscal Year
- 2013
- Product Type
- Biologics
- Project Area
- Blood and Blood Products
- Location
- Elgin, IL (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 51 | 21 CFR 606.40(c) | Provide adequate toilet facilities |
| 78 | 21 CFR 606.100(c) | Record review prior to release |
| 9225 | 21 CFR 606.171 | Biological product deviation report |
| 9236 | 21 CFR 630.40(b)(1) | Deferred or not eligible |
| 98 | 21 CFR 606.100(c) | Thorough investigations |