FDA 483 - Nev's Ink Inc. - January 22, 2019

An FDA inspection of Nev's Ink Inc., a medical device manufacturer in Waukesha, WI, revealed significant deficiencies across its quality system. The firm was cited for inadequate procedures and documentation related to complaint investigations, control of nonconforming product, corrective and preventive actions, document approval, and personnel training. Additionally, the company lacked written procedures for medical device reporting.