FDA 483 - Edge Pharma, LLC - March 30, 2020

Edge Pharma, LLC received a Form 483 citing significant deficiencies across its manufacturing, quality control, and facility operations. Key issues include inadequate investigations into product recalls, sterility failures, and customer complaints, as well as widespread problems with environmental monitoring, aseptic processing, stability testing, and equipment qualification. The report also highlights failures in data integrity, material control, and compliance with adverse event reporting and labeling requirements for an outsourcing facility.