FDA WARNING_LETTER - Encompass Group, LLC - December 22, 2009

On December 15-22, 2009, an FDA inspection of Thermoflect's McDonough, Georgia facility, a specification developer and distributor of hypothermia prevention products (devices), revealed significant violations. The firm's devices were deemed misbranded under 21 U.S.C. 352(t)(2) due to failure to furnish required information under 21 U.S.C. 360i and 21 CFR Part 803 (Medical Device Reporting - MDR).

The primary MDR violation was the failure to develop, maintain, and implement written MDR procedures as required by 21 CFR 803.17. The existing complaint handling procedure (QSR-116, Revision 1) lacked processes for timely and effective identification, communication, and evaluation of MDR-reportable events. The firm's response, anticipating a rewritten complaint procedure by April 2010, was deemed inadequate due to lack of documented implementation evidence.

Additionally, the inspection identified nonconformances with Current Good Manufacturing Practice (CGMP) requirements of the Quality System (QS) regulation (21 CFR Part 820), including: 1. Failure to establish and maintain adequate corrective and preventive action (CAPA) procedures (21 CFR 820.100(a)), with CAPAs lacking documentation of complete implementation, investigation, and verification