FDA 483 - Life Recovery Systems HD, LLC - October 21, 2019

An FDA inspection of Life Recovery Systems HD, LLC, a medical device manufacturer in Kinnelon, NJ, revealed two significant observations. The firm failed to establish adequate procedures for the rework of nonconforming products, specifically regarding O-ring components in Thermosuit Disposable Kits. Additionally, the company did not properly investigate complaints involving potential device failures, lacking sufficient rationale for not conducting investigations.