Warning letter
Medivance Instruments Ltd.: warning letter of Feb 13, 2023
FDA warning letter 647562 · Center for Devices and Radiological Health
Key facts
| Reference number | 647562 |
|---|---|
| Company | Medivance Instruments Ltd. |
| Subject | Medical Device/Adulterated/Misbranded/Lacks PMA and/or 510(k) |
| Issue date | Feb 13, 2023 |
| Posted date | Apr 25, 2023 |
| Issuing office | Center for Devices and Radiological Health |
| Product type | Devices |
| CFR sections cited | 803.17(a)(1), 803.17(b), 807.81(b), 803.50(a), 820, 807.81(a)(3), 803, 803.17, 803.50, 803.3(w) |
| Inspection city | London |
| Inspection start date | Aug 8, 2022 |
| Letter on fda.gov | fda.gov |
At a glance
- 10–99 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: