Thermedx LLC – FDA Warning Letter, Dec 11, 2014

The FDA issued Warning Letter WL-15-448762-14 to Thermedx, LLC, following an inspection from November 19 to December 11, 2014. The inspection revealed that Thermedx's fluid management systems are adulterated under 21 U.S.C. § 351(h) due to non-conformity with Quality System (QS) regulation (21 CFR Part 820). The firm's January 14, 2015, response to the FDA 483 was not reviewed due to late submission.

Key violations include: 1. **Failure to establish adequate CAPA procedures (21 CFR 820.100(a))**: No appropriate corrective actions for non-conformities, such as CAPA 2013-007 regarding incorrect fluid deficit calculation (a Class II recall, severity 10 hazard). Additionally, 17 of 21 software upgrades, including fixes for fluid deficit issues (severity 10), were not evaluated for potential corrections and removals. 2. **Failure to maintain Device History Records (DHRs) (21 CFR 820.184)**: 14 of 17 DHRs reviewed showed devices not meeting fluid pressure specifications; 6 failed the 10% tolerance, and