Ohio Contract Devicemaker Cited for Risk Management

The FDA hit Ohio contract device manufacturer Valtronic Technologies with a Form 483 for inadequate risk management procedures at its Solon facility.

The agency’s investigator found that the firm’s procedure for handling nonconforming materials was unclear.

The facility’s supplier qualification and rating procedure was found to be inadequate, as it contained unclear instructions on when to reevaluate suppliers. It also included criteria for reevaluation but lacked information on how to gather and assess the data.