Life Recovery Systems HD, LLCOctober 21, 2019

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

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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.

Company: Life Recovery Systems HD, LLC
Inspection Date: October 21, 2019
Product Type: Device
Office: New Jersey District Office
People: Diane B. Radice
William R. Chang

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ID · f869d823-8b3a-4217-a86b-e54e35e1bb1c