FDA 483 - Medical Specialties Distributors LLC - July 09, 2018

During an FDA inspection conducted from June 26 to July 9, 2018, Medical Specialties Distributors LLC, a repacker/relabeler of medical devices located in Hanover Park, IL, received a Form FDA 483 detailing significant quality system deficiencies. The inspection revealed eight observations, primarily indicating a lack of adequately established and implemented procedures critical for ensuring product quality and regulatory compliance, under the medical device Quality System Regulation.

Key issues included insufficient procedures for training, with a lead technician not retrained on nonconformance for nine years. The firm also lacked established procedures for internal quality audits, corrective and preventive actions (CAPA), and controlling nonconforming product. Furthermore, no procedures were in place for fundamental quality processes such as acceptance activities for incoming components, in-process product control, and finished device acceptance. A major finding was the absence of written Medical Device Reporting (MDR) procedures, essential for reporting adverse events.

Medical Specialties Distributors LLC acknowledged all observations and committed to implementing corrective actions to address each identified deficiency, which is required to resolve the non-compliance issues and ensure patient safety and product quality.