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Fagron Group B.V.'s Saint Paul, Minnesota facility was cited for significant deviations from current good manufacturing practice (CGMP) in the production of active pharmaceutical ingredients (APIs), rendering their products adulterated. The company failed to perform adequate cleaning validation studies for non-dedicated production cabins used to repackage highly potent drugs including testosterone, estradiol, betamethasone, tamoxifen, and opioids, creating potential cross-contamination risks. An outdated 2008 cleaning validation study did not reflect current practices, and the company acknowledged the need for revalidation, having only provided preliminary results for niacin and progesterone residue testing during the November 2021 inspection.