Life Recovery Systems HD, LLC – FDA Warning Letter, Jan 4, 2012

This FDA Warning Letter, dated December 8, 2011, to Life Recovery Systems HD, LLC, details violations of the Quality System (QS) regulation (21 CFR Part 820) for their ThermoSuit System, a medical device. An inspection from December 8, 2011, to January 4, 2012, revealed the device to be adulterated under section 501(h) of the Federal Food, Drug, and Cosmetic Act.

Key violations include:

1. **Failure to establish and maintain corrective and preventive action (CAPA) procedures (21 CFR 820.100(a)):** * The firm failed to adequately determine the root cause and provide effective solutions for TSP-50 Pump controller units (used with ThermoSuit System) that were out of calibration by up to 5 degrees Celsius, leading to erroneous patient temperature readings. For example, CAPA #10004 for complaints 1003, 1005, 1006, and 1008 resulted in a manual revision for a 6-month calibration check without proper root cause analysis. * The firm failed to verify or validate the effectiveness of corrective and preventive actions. For instance, CAPA #11002, initiated due to a TSP-50 Pump controller displaying 39