FDA 483 - General Devices Llc - June 11, 2015

An FDA inspection of 86 Harriet Ave Corporation DBA General Devices, a medical device manufacturer in Ridgefield, NJ, revealed significant deficiencies in their quality system. The firm failed to adequately establish procedures for corrective and preventative actions, medical device reporting, and design changes. These issues indicate a lack of robust controls over product quality and safety.