Warning letter
Beckman Coulter Inc.: warning letter of Mar 15, 2024
FDA warning letter 678042 · Division of Medical Device and Radiological Health Operations Central
Key facts
| Reference number | 678042 |
|---|---|
| Company | Beckman Coulter Inc. |
| Subject | CGMP/QSR/Medical Devices/Adulterated |
| Issue date | Mar 15, 2024 |
| Posted date | Apr 2, 2024 |
| Issuing office | Division of Medical Device and Radiological Health Operations Central |
| Product type | Devices |
| CFR sections cited | 820 |
| Inspection city | Chaska |
| Inspection ZIP | 55318 |
| Inspection start date | Nov 1, 2023 |
| Letter on fda.gov | fda.gov |
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: