FDA 483 - Keystone Industries - July 25, 2025

Keystone Industries, a medical device manufacturer in Cherry Hill, NJ, was cited for multiple significant quality system deficiencies during an FDA inspection. Observations included failures in medical device reporting, production process controls, corrective and preventive actions, complaint handling, supplier management, and internal quality audits. These issues indicate a systemic lack of adherence to regulatory requirements, potentially impacting product quality and patient safety.