FDA 483 - Kleen Test Products Corporation - March 25, 2022

Kleen Test Products Corporation, a medical device manufacturer in Port Washington, WI, was cited for inadequate process validation during an FDA inspection. The firm failed to perform a performance qualification for a checkweigher and used an inappropriate justification for not validating a medical device filling process. These deficiencies indicate significant issues with the firm's quality system regarding equipment and process validation.