Warning letter
International Biologicals, Inc.: warning letter of Oct 12, 2001
FDA warning letter UCM178238 · Center for Biologics Evaluation and Research
Key facts
| Reference number | UCM178238 |
|---|---|
| Company | International Biologicals, Inc. |
| Subject | GMP for Blood & Blood Components/Records & Reports |
| Issue date | Oct 12, 2001 |
| Posted date | Oct 12, 2001 |
| Issuing office | Center for Biologics Evaluation and Research |
| Product type | Biologics |
| CFR sections cited | 600.11, 680.1, 600.11(a) |
| Country | 3 |
| Inspection city | Piedmont |
| Inspection ZIP | 73078 |
| Inspection start date | Jul 10, 2001 |
| 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: