Warning letter
Customed, Inc: warning letter of Dec 9, 2014
FDA warning letter 440230 · San Juan District Office
Key facts
| Reference number | 440230 |
|---|---|
| Company | Customed, Inc |
| Subject | CGMP/QSR/Medical Devices/Adulterated |
| Issue date | Dec 9, 2014 |
| Posted date | Dec 9, 2014 |
| Issuing office | San Juan District Office |
| Product type | Devices |
| CFR sections cited | 820, 803, 803.3, 803.17, 803.20(c)(1), 807.81(b)(1), 878.4400, 803.50(a) |
| Inspection city | Fajardo |
| Inspection ZIP | 00738 |
| Inspection start date | Jul 14, 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: