FDA 483 - General Meditech Inc - August 22, 2024

General Meditech Inc., a medical device manufacturer in Shenzhen, China, was cited for multiple quality system deficiencies during an FDA inspection. Key issues include inadequate procedures for corrective and preventive actions, medical device reporting, environmental controls, and document control. The firm also failed to properly document rework activities and provide correct Unique Device Identifier information to the FDA.