FDA 483 - Havix Group Inc - April 19, 2022

Havix Group Inc d/b/a Aavis Pharmaceuticals, a drug manufacturer in Hoschton, GA, was cited for two observations during an FDA inspection. The firm failed to exercise appropriate controls over computer systems, allowing unauthorized personnel administrator rights, and lacked established procedures to prevent objectionable microorganisms. Specifically, issues were noted with cleaning validation for non-dedicated equipment and clean equipment hold times.