FDA 483 - Kleen Test Products Corporation - June 14, 2006

An FDA inspection of Kleen Test Products in Port Washington, WI, from June 8-14, 2006, revealed a significant quality control failure. The firm failed to thoroughly review an unexplained discrepancy where the wrong lot code for an active drug ingredient was listed in a batch record for an over-the-counter drug product. This indicates a lapse in their investigation and quality control processes.