Warning letter
F Care Systems USA: warning letter of Jun 12, 2012
FDA warning letter 303318 · Florida District Office
Key facts
| Reference number | 303318 |
|---|---|
| Company | F Care Systems USA |
| Subject | Medical Device Reporting/Misbranded/Adulterated |
| Issue date | Jun 12, 2012 |
| Posted date | Jun 12, 2012 |
| Issuing office | Florida District Office |
| Product type | Devices |
| CFR sections cited | 820.40, 803, 803.17, 807.81(a)(3)(i), 807.81(a)(3)(ii), 820, 807.81(b) |
| Inspection city | Miami |
| Inspection ZIP | 33162 |
| Inspection start date | Mar 28, 2012 |
| 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: