FDA 483 - Life Recovery Systems HD, LLC - September 11, 2023

An FDA inspection of Life Recovery Systems HD, LLC in Kinnelon, NJ, a medical device manufacturer, revealed significant deficiencies in their quality system. The firm failed to adequately establish procedures for verifying the effectiveness of corrective and preventive actions. Additionally, the company did not properly control non-conforming incoming product, as evidenced by a lack of non-conformance reports for rejected materials.