FDA Inspection 1026545 — Biomat USA, Inc.
The FDA completed an inspection of Biomat USA, Inc. on September 22, 2017 in Erie, PA. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 4 citations were issued during this inspection. Product area: Biologics.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- September 22, 2017
- Fiscal Year
- 2017
- Product Type
- Biologics
- Project Area
- Blood and Blood Products
- Location
- Erie, PA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1033 | 21 CFR 211.22(a) | Authority lacking to review records, investigate errors |
| 154 | 21 CFR 606.160(a)(1) | Concurrent documentation |
| 35 | 21 CFR 606.40 | Clean & orderly |
| 67 | 21 CFR 606.65(e) | Following manufacturer's instructions |