FDA EIR - Myelotec, Inc. - February 28, 2017

An FDA inspection of Myelotec, Inc. in Roswell, GA, a manufacturer of sterile Class II spinal steerable catheters, was conducted from January 18 to February 1, 2017. The inspection, a Level I QSIT review under Compliance Program 7382.845 for Medical Device Manufacturers, revealed significant deviations from the Quality System Regulations. Eight observations were cited. Key issues included the failure to submit Medical Device Reports (MDRs) for devices that malfunctioned during patient surgery, indicating a potential for serious harm. The firm lacked adequate design validation and approved engineering specifications for its Video Guided Catheter (VGC) model 2010, resulting in the distribution of devices with obstructed side ports. Production processes were not properly controlled to ensure product conformity, and Corrective and Preventive Actions (CAPAs) were voided or inadequately investigated instead of addressing root causes, such as sterilization issues or manufacturing defects. Furthermore, Myelotec, Inc. had not established sufficient procedures for handling and disposing of non-conforming products. Its quality system procedures and employee training programs were found to be outdated and inadequate, with no formal Good Manufacturing Practices (GMP) training for personnel. The company also failed to perform regular internal quality audits to ensure compliance. Management committed to correcting all observations and was advised to contact the FDA Recall Coordinator regarding potentially defective products.