Warning letter
Centurion Medical Products Corporation: warning letter of Jun 11, 2020
FDA warning letter 598837 · Division of Medical Device and Radiological Health Operations East
Key facts
| Reference number | 598837 |
|---|---|
| Company | Centurion Medical Products Corporation |
| Subject | CGMP/QSR/Medical Devices/PMA/Adulterated/Misbranded |
| Issue date | Jun 11, 2020 |
| Posted date | Jul 21, 2020 |
| Issuing office | Division of Medical Device and Radiological Health Operations East |
| Product type | Devices |
| CFR sections cited | 3.2(e)(2), 801, 820, 807.81(b) |
| Inspection city | Howell |
| Inspection ZIP | 48843 |
| Inspection start date | Aug 5, 2019 |
| 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: