FDA 483 - Myelotec, Inc. - February 01, 2017

Myelotec, Inc. in Roswell, GA, a medical device manufacturer, was cited for numerous quality system deficiencies during an FDA inspection. Key issues include failure to report medical device malfunctions (MDRs), inadequate design validation for their Video Guided Catheter, and uncontrolled production processes leading to defective products. The firm also failed to properly document corrective actions, establish procedures for nonconforming products, maintain updated quality system procedures, provide GMP training, and conduct required internal quality audits, indicating systemic quality control failures.