FDA 483 - Meridian Medical Technologies, LLC a Subsidiary of Kindeva Drug Delivery, L.P. - February 21, 2014

This FDA Form 483 report details numerous deficiencies at Meridian Medical Technologies, Inc., a Pfizer Company, concerning the aseptic processing and quality control of multichambered autoinjectors. The observations highlight significant issues in media fill validation, environmental monitoring, personnel practices, equipment maintenance, and data integrity for automated inspection systems. These findings indicate a lack of robust controls necessary to ensure the sterility and quality of their drug products.