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

Myelotec, Inc. in Roswell, GA, was inspected and cited for significant quality system deficiencies related to its Video Guided Catheter model 2010. The inspection revealed failures in submitting MDRs, inadequate design validation, uncontrolled production processes, and poor documentation of CAPAs. Additionally, the firm lacked established procedures for nonconforming product disposition, outdated quality system procedures, insufficient employee training, and non-compliant internal quality audits.