Warning letter
Jade & Pearl, Inc.: warning letter of May 9, 2014
FDA warning letter 420680 · Florida District Office
Key facts
| Reference number | 420680 |
|---|---|
| Company | Jade & Pearl, Inc. |
| Subject | Medical Device Reporting/Premarket Approval/Misbranded |
| Issue date | May 9, 2014 |
| Posted date | May 20, 2014 |
| Issuing office | Florida District Office |
| Product type | Devices |
| CFR sections cited | 820, 807.81(b), 884.3575, 884.5460, 884.5470, 803, 803.17 |
| Inspection city | Hawthorne |
| Inspection ZIP | 32640 |
| Inspection start date | Dec 10, 2013 |
| 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: