FDA 483 - Meridian Medical Technologies, LLC a Subsidiary of Kindeva Drug Delivery, L.P. - December 21, 2019

Meridian Medical Technologies, Inc., a Pfizer Company, received an FDA Form 483 following an inspection from December 9-21, 2019. The observations detailed significant deficiencies in the company's quality management system for manufacturing EpiPen, EpiPen Jr., and Epinephrine Authorized Generic auto-injectors. Key issues included inadequate procedures for corrective and preventive actions (CAPA), specifically failing to prevent recurrent device failures like spontaneous activation or "zip fire" linked to the blue safe pin, despite years of post-market feedback. The regulatory framework requires robust quality systems for medical devices. Design control weaknesses were noted, with inadequate design verification not confirming component functionality for activation and safety pin removal forces. Risk analysis procedures were found poorly defined, lacking traceability and potentially leading to inaccurate reliability assessments. Furthermore, the inspection revealed deficiencies in design validation, supplier qualification, finished device acceptance, incoming product acceptance, and the stability program, with critical tests and specifications lacking sufficient justification or validation. Process validation for leak detection and design transfer of specifications also showed shortcomings. Meridian Medical Technologies is required to address these observations by thoroughly reviewing and enhancing its quality system to ensure the safety and effectiveness of its auto-injector products, ensuring full compliance with regulatory requirements.