FDA 483 - The Peavey Corporation dba Lynn Peavey Co. - January 10, 2023

The Peavey Corporation dba Lynn Peavey Co. in Lenexa, KS, was inspected and cited for significant deficiencies in its quality system. Observations include a lack of process validation for sterilization, inadequate purchasing controls, undocumented personnel training, and the absence of internal quality audits and management reviews. These issues indicate a broad failure to establish and implement essential quality system procedures for medical device manufacturing.