F Care Systems USA, LLC – FDA Warning Letter, Mar 30, 2012

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