Warning letter
Ortho-Cycle Company Inc.: warning letter of May 16, 2013
FDA warning letter 397344 · Florida District Office
Key facts
| Reference number | 397344 |
|---|---|
| Company | Ortho-Cycle Company Inc. |
| Subject | CGMP/QSR/Manufacture/Packing/Storage/Installation/Adulterated |
| Issue date | May 16, 2013 |
| Posted date | May 16, 2013 |
| Issuing office | Florida District Office |
| Product type | Devices |
| CFR sections cited | 820, 803.50, 803.20(c)(1), 803.50(b)(3), 803, 803.3, 803.17 |
| Inspection city | Hollywood |
| Inspection ZIP | 33020 |
| Inspection start date | Mar 11, 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: