Loading…
Xtreme Tools International, Inc. received a warning letter for significant Current Good Manufacturing Practice (CGMP) violations in its drug manufacturing facility in Opa Locka, Florida, specifically related to over-the-counter topical drug products. The company failed to conduct identity testing on incoming component lots and did not validate or verify supplier test results at appropriate intervals, such as failing to independently test salicylic acid used in its Okay Miami Salicylic Acid Foaming Scrub product. The firm's response to FDA's initial inspection findings was deemed inadequate because it lacked supporting documentation and sufficient evidence of corrective actions, rendering the drug products adulterated and unsuitable for the U.S. market.