FDA WARNING_LETTER - Encore Medical, L.P. - January 11, 2008

On January 8-11, 2008, an FDA inspection of Encore Medical, LP, dba Chattanooga Group, revealed that their muscle stimulators and ultrasound devices were adulterated under 21 USC 351(h) due to non-conformity with CGMP requirements of 21 CFR 820. The firm also misbranded devices under 21 USC 352(t)(2) by failing to furnish required information under 21 USC 360(i) and 21 CFR 803 (MDR regulation).

Violations included: 1. **Failure to establish and maintain adequate CAPA procedures (21 CFR 820.100(a)(3))**: * The firm received 64 complaints (58 after January 2007) of shock/burns from muscle stimulator EPR product line due to transient over-voltage. Software revisions were only installed in stock or returned devices, not those in distribution. * In 2005, the firm identified failing diodes in ultrasound Vectra Genisys devices. Only in-stock boards were modified; devices in distribution were not addressed, leading to 50 complaints of shock/burns after a correction was identified in March 2007. * The firm failed to provide written CAPA documentation for ultrasound devices (2