# FDA WARNING_LETTER - F Care Systems USA, LLC - March 30, 2012

Source: https://www.keypedia.com/records/warning_letter/f-care-systems-usa-llc/4d3ec27c-8adc-4152-bd44-a74476b71eff

> FDA WARNING_LETTER for F Care Systems USA, LLC on March 30, 2012. Product: Devices. Access full analysis and detailed observations.

---

## Details

- Record Type: WARNING_LETTER
- Company Name: F Care Systems USA, LLC
- Inspection Date: 2012-03-30
- Product Type: Devices
- Office Name: Department of Health and Human Services
- Summary: On March 28-30, 2012, an FDA inspection of F Care Systems USA, LLC in Miami Shores, Florida, revealed that their Endo Venous Radio Frequency (EVRF), TC3000, and Veinwave devices were adulterated under 21 U.S.C. § 351(h) due to non-conformity with Quality System (QS) regulation (21 CFR Part 820). The firm's April 16, 2012, response to the FDA 483 was deemed inadequate.

Key violations include:
1.  **Failure to establish and maintain CAPA procedures (21 CFR 820.100(a))**: No written procedures, and the new procedure lacked retrospective review and evidence of implementation.
2.  **Failure to establish and maintain complaint handling procedures (21 CFR 820.198(a))**: No procedures, and 11 of 24 complaint files lacked required information. New procedure's application to existing complaints and implementation evidence were unclear.
3.  **Failure to establish and maintain servicing instructions and procedures (21 CFR 820.200(a))**: No procedures for PCB replacement, testing, or documenting service. New SOPs were not provided.
4.  **Failure to establish and maintain documented service reports (21

## Related Officers

- [District Director](https://www.keypedia.com/people/emma-r-singleton/e0b72aba-caa5-4cf8-8beb-6f93f6654e59)

Company: https://www.keypedia.com/companies/f-care-systems-usa-llc/d9064894-2eae-4895-9fdd-1fb865df0cd8

Office: https://www.keypedia.com/offices/department-of-health-and-human-services/cecfcda4-4afa-4a1f-a7b7-a020b79f9861