Warning letter
Cotton High Tech S.L. (d/ba COHITECH): warning letter of Jan 23, 2014
FDA warning letter 415941 · Center for Devices and Radiological Health
Key facts
| Reference number | 415941 |
|---|---|
| Company | Cotton High Tech S.L. (d/ba COHITECH) |
| Subject | Quality System Regulation for Medical Devices/Adulterated/Misbranded |
| Issue date | Jan 23, 2014 |
| Posted date | Jun 10, 2014 |
| Issuing office | Center for Devices and Radiological Health |
| Product type | Devices |
| CFR sections cited | 820, 801.430, 820.40 |
| Inspection city | Balsareny |
| Inspection start date | Aug 5, 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: