Warning letter
Universal Reagents Inc.: warning letter of Jul 20, 2000
FDA warning letter UCM068635 · Detroit District Office
Key facts
| Reference number | UCM068635 |
|---|---|
| Company | Universal Reagents Inc. |
| Subject | Current Good Manufacturing Practice for Blood & Blood Products/Plasmapheresis Facility |
| Issue date | Jul 20, 2000 |
| Posted date | Jul 20, 2000 |
| Issuing office | Detroit District Office |
| Product type | Biologics |
| CFR sections cited | 606.100(b)(10), 606.100(b), 606, 606.100, 606.60(a), 606.100(b)(14), 606.160(b)(5)(i) |
| Country | 3 |
| Inspection city | Indianapolis |
| Inspection ZIP | 46205-4125 |
| Inspection start date | Jun 12, 2000 |
| Letter on fda.gov | web.archive.org |
At a glance
- 1–9 CFR sections cited
- 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: