Life Recovery Systems HD, LLCSeptember 11, 2023

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

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Record Details

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.

Company: Life Recovery Systems HD, LLC
Inspection Date: September 11, 2023
Product Type: Device
Office: New Jersey District Office
People: Jonathan Ho
Nakesh N. Gomanie
Matthew W. Kyle (issuing_officer)

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ID · b0684ac9-1a1b-4941-8081-dff40761af1b