FDA Inspection 1071532 — Biomat USA, Inc.
The FDA completed an inspection of Biomat USA, Inc. on Nov 13, 2018 in Jacksonville, 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). 3 citations were issued during this inspection. Product area: Biologics.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Nov 13, 2018
- Fiscal Year
- 2019
- Product Type
- Biologics
- Project Area
- Blood and Blood Products
- Location
- Jacksonville, FL (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 18093 | 21 CFR 630.10(g)(1) | Proof Of Identity |
| 31 | 21 CFR 606.20(b) | Qualifications of responsible personnel |
| 9225 | 21 CFR 606.171 | Biological product deviation report |