Warning letter
BioMerieux, Inc.: warning letter of Jul 8, 2004
FDA warning letter UCM146496 · Atlanta District Office
Key facts
| Reference number | UCM146496 |
|---|---|
| Company | BioMerieux, Inc. |
| Subject | CGMP Requirement of the Quality System Regulation for Medical Devices/Adulterated |
| Issue date | Jul 8, 2004 |
| Posted date | Jul 8, 2004 |
| Issuing office | Atlanta District Office |
| Product type | Devices |
| CFR sections cited | 803.50(a)(1), 803 |
| Country | 3 |
| Inspection city | Durham |
| Inspection ZIP | 27712-9402 |
| Inspection start date | Apr 13, 2004 |
| Letter on fda.gov | web.archive.org |
At a glance
- 1–9 CFR sections cited
- 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: