FDA 483 - Nova-Tech Inc. - May 12, 2023

Nova-Tech Inc. in Grand Island, NE, an animal drug manufacturer, was inspected by the FDA from May 9-12, 2023. The inspection revealed two significant issues related to laboratory controls and procedures for preventing microbiological contamination in sterile drug products. Specifically, the firm failed to perform adequate growth promotion testing for microbiological media and an operator was observed sanitizing hands immediately prior to personnel monitoring in a cleanroom.