FDA Inspection 1243776 — Biomat USA Inc
The FDA completed an inspection of Biomat USA Inc on Jul 11, 2024 in Goldsboro, NC. 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
- Jul 11, 2024
- Fiscal Year
- 2024
- Product Type
- Biologics
- Project Area
- Blood and Blood Products
- Location
- Goldsboro, NC (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 154 | 21 CFR 606.160(a)(1) | Concurrent documentation |
| 157 | 21 CFR 606.160(d) | Retention period |
| 4425 | 21 CFR 606.60(a) | Equipment observed, standardized, calibrated |