FDA 483 - Innovative Medical Equipment - March 10, 2022

Innovative Medical Equipment, a medical device manufacturer in Beachwood, OH, received a Form 483 with four observations. The inspection revealed deficiencies in risk analysis for their Thermazone hot/cold therapy device, inadequate procedures for supplier qualification, and a lack of defined statistical methodologies for CAPA trend analysis. Additionally, the firm failed to adequately document design verification results and test equipment for their ROM knee brace, indicating significant quality system gaps.