FDA 483 - Silex Medical, LLC - April 23, 2025

Silex Medical, LLC, a medical device manufacturer in Southington, CT, was cited for six significant quality system deficiencies during an FDA inspection. Key issues include failures in reporting device corrections and removals, lack of risk analysis, inadequate control of nonconforming products, and deficiencies in corrective and preventive action procedures. The inspection also highlighted problems with finished device acceptance and a repeat observation regarding inadequate complaint handling.