483
Life Recovery Systems HD, LLCLife Recovery Systems HD, LLC – FDA 483, Oct 21, 2019
Record Details
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.
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ID · f869d823-8b3a-4217-a86b-e54e35e1bb1c
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