FDA 483 - Avea Biopharmaceuticals LLC - March 23, 2016

This FDA Form 483 report for Avea Biopharmaceuticals LLC in Irvine, CA, identifies significant deficiencies in the manufacturing of sterile drug products. The firm was cited for inadequate environmental monitoring, insufficient disinfectant efficacy studies, and a lack of proper validation for aseptic processes. Additional concerns include inadequate employee training for visual inspection, unsound laboratory controls for container closure integrity, and the absence of written procedures for master production records, indicating a high severity of non-compliance with GMP regulations.