Warning letter
LockDown Medical Ltd.: warning letter of Sep 11, 2014
FDA warning letter 438136 · Center for Devices and Radiological Health
Key facts
| Reference number | 438136 |
|---|---|
| Company | LockDown Medical Ltd. |
| Subject | Medical Devices/Adulterated/Quality System Regulation (QSR) |
| Issue date | Sep 11, 2014 |
| Posted date | Sep 11, 2014 |
| Issuing office | Center for Devices and Radiological Health |
| Product type | Devices |
| CFR sections cited | 806, 803, 803.3, 803.17, 803.50(a)(2), 820, 820.40, 803.50(a) |
| Inspection city | Redditch |
| Inspection start date | Jun 2, 2014 |
| Letter on fda.gov | web.archive.org |
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: