Warning letter
International Diagnostic & Medical Supply Corporation: warning letter of Sep 6, 2000
FDA warning letter UCM068818 · Florida District Office
Key facts
| Reference number | UCM068818 |
|---|---|
| Company | International Diagnostic & Medical Supply Corporation |
| Subject | Hema-Strip HIV-1/2 Test Kit/Lacks Investigational Device Exemption/Export Listing Violation |
| Issue date | Sep 6, 2000 |
| Posted date | Sep 6, 2000 |
| Issuing office | Florida District Office |
| Product type | Biologics |
| Country | 3 |
| Inspection city | North Bay Village |
| Inspection ZIP | 33141 |
| Inspection start date | Mar 14, 2000 |
| Letter on fda.gov | web.archive.org |
At a glance
- OAI 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: