FDA 483 - Nasiff Associates, Inc - February 11, 2020

Nasiff Associates, Inc, a medical device manufacturer in Central Square, NY, was inspected by the FDA from February 6-11, 2020. The inspection revealed that corrective and preventive action (CAPA) activities and results were not adequately documented. Specifically, 6 of 11 CAPA files reviewed lacked required information or detail according to the firm's own procedures.