483
Cosmed Group, Inc. dba Cosmed of PA.Cosmed Group, Inc. dba Cosmed of PA. – FDA 483, Mar 11, 2026
Record Details
An FDA inspection of Lynx Medical Pennsylvania, a contract medical device sterilizer in Erie, PA, revealed significant deficiencies in their risk management processes. The firm's FMEA Risk Analysis procedures were found inadequate, with unclear severity and detection rankings not consistently related to patient harm. This indicates a critical quality system issue regarding the safety and efficacy of their medical device sterilization processes.
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ID · 1a5cab0e-db17-4a82-84b4-e5f21462f6b8
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