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Ardil Comercial S.R.L., a Dominican Republic-based drug manufacturer, was cited for manufacturing and attempting to import an unapproved hand sanitizer product (Alcohol Isopropilico Hand Sanitizer Limar) that violated multiple FDA regulations including adulteration, misbranding, and unapproved new drug status. FDA laboratory testing of a detained batch confirmed the product was adulterated because it contained substituted substances and failed to meet Current Good Manufacturing Practice (CGMP) requirements for quality assurance. The product was labeled as containing 70% isopropyl alcohol but FDA testing revealed it did not meet this specification, resulting in border detention and refusal of admission into the United States.