Warning letter
Innova Medical Group, Inc.: warning letter of Jun 10, 2021
FDA warning letter 614819 · Center for Devices and Radiological Health
Key facts
| Reference number | 614819 |
|---|---|
| Company | Innova Medical Group, Inc. |
| Subject | Unapproved and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19) |
| Issue date | Jun 10, 2021 |
| Posted date | Jun 10, 2021 |
| Issuing office | Center for Devices and Radiological Health |
| Product type | Devices |
| CFR sections cited | 803, 803.17, 803.50, 803.53, 820 |
| Inspection city | Pasadena |
| Inspection ZIP | 91101 |
| Inspection start date | Mar 15, 2021 |
| 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: