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Iso-Tex Diagnostics, Inc. was cited for Current Good Manufacturing Practice (CGMP) violations in their drug manufacturing facility that rendered their drug products adulterated. FDA inspectors found that the company failed to maintain properly designed cleanrooms with adequate materials for cleaning and disinfection, and failed to establish sufficient environmental monitoring and control systems in aseptic processing areas to prevent contamination of sterile drug products. The facility's deficient design, unsuitable equipment, and inadequate environmental conditions created significant contamination risks for drugs intended to be sterile.