FDA EIR - Avella Specialty Pharma - July 26, 2012

An FDA-directed investigation was conducted at Avella, a specialty compounding pharmacy in Phoenix, AZ, from July 23-26, 2012. The inspection was initiated following a consumer complaint dated July 11, 2012, involving a sterile injectable drug, Avastin. A patient reportedly developed a severe bacterial infection and complete blindness in his right eye after receiving an Avastin injection from a specific lot prepared by Avella. The FDA's Office of Emergency Operations, Center for Drug Evaluation and Research, and the Los Angeles district Office of Regulatory Affairs coordinated the investigation in conjunction with the State of Arizona Board of Pharmacy. The review focused on Avella's complaint procedures, training, aseptic compounding operations, certifications, and batch records, including sterility testing. Crucially, at the conclusion of the inspection, investigators found no connection between the patient's adverse event and the implicated Avastin product lot. Furthermore, no manufacturing or compounding pharmacy good manufacturing practice issues were identified, and consequently, no Form FDA-483 (listing objectionable conditions) was issued to Avella. Management received two recommendations: to include syringe lot numbers on batch records (which the firm implemented during the inspection) and to conduct an in-house stability/validation study for their aseptic compounding process of Avastin syringes. Avella's accreditation was noted to meet current USP <797> standards for sterile compounding.