483
Kleen Test Products CorporationFDA 483 - Kleen Test Products Corporation - June 14, 2006
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Record Details
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.
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ID · 3f8d02fe-2319-4b14-8da5-a860b8862173