Warning letter
Biomat USA, Inc.: warning letter of Apr 22, 2003
FDA warning letter UCM147441 · Seattle District Office
Key facts
| Reference number | UCM147441 |
|---|---|
| Company | Biomat USA, Inc. |
| Subject | Current Good Manufacturing Practices for Blood and Blood Components |
| Issue date | Apr 22, 2003 |
| Posted date | Apr 22, 2003 |
| Issuing office | Seattle District Office |
| Product type | Biologics |
| CFR sections cited | 606.100(c), 606.160(a)(1), 606.171(b), 640.72(d), 640.64(e), 610.40(h), 606.60(a) |
| Country | 3 |
| Inspection city | Houston |
| Inspection ZIP | 77018-4203 |
| Inspection start date | Mar 17, 2003 |
| Letter on fda.gov | web.archive.org |
At a glance
- 1–9 CFR sections cited
- VAI Linked inspection classification
- Yes Form FDA 483 issued
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA warning letters
FDA warning letters notify a firm of significant regulatory violations found during an inspection or review and request prompt corrective action.
Source: U.S. Food and Drug Administration (FDA), Warning Letters · Source date: