FDA 483 - Nova-Tech Inc. - March 15, 2022

NovaTech Incorporated, a sterile animal drug manufacturer in Grand Island, NE, received a Form 483 citing significant deficiencies in its quality system. Observations included inadequate investigations into discrepancies, deficient complaint handling, and widespread failures in aseptic processing controls, environmental monitoring, and equipment maintenance. These issues collectively indicate a high risk of product contamination and compromise of sterility.