Warning letter
Impladent Ltd.: warning letter of Mar 28, 2014
FDA warning letter 415737 · Center for Devices and Radiological Health
Key facts
| Reference number | 415737 |
|---|---|
| Company | Impladent Ltd. |
| Subject | Sponsor/Monitor/Contract Research Organization |
| Issue date | Mar 28, 2014 |
| Posted date | May 20, 2014 |
| Issuing office | Center for Devices and Radiological Health |
| Product type | Devices |
| CFR sections cited | 812.3(m), 812.43(c), 3, 50.20, 50.25(a)(4), 50.27(a), 812.20, 812.40, 812.42, 812, 812.140(b)(2) |
| Inspection city | Jamaica |
| Inspection ZIP | 11423 |
| Inspection start date | Nov 12, 2013 |
| Letter on fda.gov | web.archive.org |
At a glance
- 10–99 CFR sections cited
- NAI Linked inspection classification
- No Form FDA 483 issued
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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: