Warning letter
Beckman Coulter, Inc. [ARCHIVED]: warning letter of Aug 9, 2011
FDA warning letter UCM268244 · Los Angeles District Office
Key facts
| Reference number | UCM268244 |
|---|---|
| Company | Beckman Coulter, Inc. [ARCHIVED] |
| Subject | CGMP/QSR/Medical Devices/Adulterated |
| Issue date | Aug 9, 2011 |
| Posted date | Aug 9, 2011 |
| Issuing office | Los Angeles District Office |
| Product type | Devices |
| CFR sections cited | 806.10(a)(1), 803.50(b), 803, 803.17, 806, 803.50(a)(2), 803.52(e)(3), 803.52(f)(7), 803.52(f)(9), 820 |
| Country | 3 |
| Inspection city | Brea |
| Inspection ZIP | 92821 |
| Inspection start date | Mar 1, 2011 |
| Letter on fda.gov | web.archive.org |
At a glance
- 10–99 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: