FDA 483 - Vitalab Pharmacy, Inc. DBA Vasco Rx Specialty Pharmacy - April 04, 2018

An FDA inspection of Vitalab Pharmacy, Incorporated (dba Vasco Pharmacy) in Phoenix, AZ, conducted from March 26 to April 4, 2018, revealed significant deficiencies in its sterile drug production operations. The agency issued a Form FDA 483 citing five observations that indicate potential non-compliance with current Good Manufacturing Practice (cGMP) regulations. Key issues included inadequate HEPA filter coverage and airflow in the laminar flow hood, compromising aseptic processing for products like TriMix. The firm was also observed using non-sterile cleaning wipes and disinfectants in ISO 5 classified aseptic processing areas. Additionally, personnel failed to adequately cover their upper faces during aseptic processing, and media fill studies were not comprehensive, omitting high-volume or manually intensive formulations. Finally, a technician was observed manually contacting the inner surface of a container closure during aseptic vial stoppering for products such as Progesterone 50mg/mL injection. Vitalab Pharmacy is expected to implement prompt and effective corrective actions to resolve these issues and ensure the sterility and quality of its drug products.