Warning letter
Carroll-Baccari, Inc. dba Mavidon Medical Products: warning letter of Apr 17, 2020
FDA warning letter 598514 · Division of Medical Device and Radiological Health Operations Central
Key facts
| Reference number | 598514 |
|---|---|
| Company | Carroll-Baccari, Inc. dba Mavidon Medical Products |
| Subject | CGMP/QSR/Medical Devices/Adulterated |
| Issue date | Apr 17, 2020 |
| Posted date | Apr 28, 2020 |
| Issuing office | Division of Medical Device and Radiological Health Operations Central |
| Product type | Devices |
| CFR sections cited | 803.17(a)(1), 803, 803.3, 803.17, 803.17(a)(3), 803.17(b), 803.50(a)(2), 820, 803.50(a) |
| Inspection city | Flat Rock |
| Inspection ZIP | 28731 |
| Inspection start date | Oct 2, 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: