FDA 483 - Geneva Woods Pharmacy Inc - April 16, 2019

An FDA 483 was issued to Geneva Woods Pharmacy, Inc. dba Geneva Woods Pharmacy, following an inspection conducted from April 9-12 and 15-16, 2019. The company, a producer of non-sterile drug products, received observations related to inadequate controls for preventing cross-contamination of drug products. The primary issues involved the production of beta-lactam drugs and hazardous drugs. For beta-lactam products, the inspection noted insufficient containment, cleaning of work surfaces, equipment, and personnel practices. Beta-lactam drugs were produced in a non-hazardous area using shared surfaces and equipment with non-beta-lactam products, without dedicated equipment or adequate cleaning protocols to prevent carryover. Similarly, for hazardous drugs like testosterone and progesterone, the pharmacy failed to provide adequate cleaning of shared equipment, raising concerns about potential cross-contamination between different hazardous drug products. These observations highlight potential deviations from established good manufacturing practices concerning facility and equipment control. The company is required to review these observations and submit a formal response outlining its corrective actions to address the identified deficiencies and ensure product quality and patient safety.