Warning letter
Denterprise International, Inc.: warning letter of Oct 9, 2019
FDA warning letter 586932 · Division of Medical Device and Radiological Health Operations Central
Key facts
| Reference number | 586932 |
|---|---|
| Company | Denterprise International, Inc. |
| Subject | CGMP/QSR/Medical Devices/Adulterated |
| Issue date | Oct 9, 2019 |
| Posted date | Oct 15, 2019 |
| Issuing office | Division of Medical Device and Radiological Health Operations Central |
| Product type | Devices |
| CFR sections cited | 820, 1002.20, 1002.20(a) |
| Inspection city | Ormond Beach |
| Inspection ZIP | 32176 |
| Inspection start date | May 1, 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: