FDA 483 - Avella of Deer Valley dba Avella Specialty Pharmacy - July 31, 2015

During an FDA inspection conducted from July 20 to July 31, 2015, Avella of Deer Valley, Inc. (dba Avella), an outsourcing facility in Phoenix, AZ, was issued a Form FDA 483 for significant observations related to its sterile drug product manufacturing and labeling practices. The inspection highlighted deficiencies in the firm's quality systems, particularly concerning the maintenance of aseptic conditions and compliance with drug labeling regulations under section 503B of the Federal Food, Drug, and Cosmetic Act.Key violations included an inadequate environmental monitoring system for aseptic processing areas (ISO 5 hoods and ISO 7 clean rooms), where viable air and surface sampling frequencies were insufficient and not conducted daily as expected for sterile drug production. Furthermore, the firm failed to maintain equipment used to control aseptic conditions, specifically lacking proper cleaning procedures and logs for chairs within aseptic laboratories. An investigator observed a technician using a non-impervious, difficult-to-clean chair during sterile drug manufacturing.Additionally, numerous drug product labels and containers lacked critical information mandated by section 503B(a)(10)(A) and (B). Missing details included the statement "This is a compounded drug," storage and handling instructions, "Not for resale," dosage form, a complete list of active and inactive ingredients with quantities, and information to facilitate adverse event reporting. Avella is required to address these observations by implementing comprehensive corrective and preventive actions to ensure compliance with federal regulations governing drug compounding and quality manufacturing.