FDA 483 - Meridian Medical Technologies, LLC a Subsidiary of Kindeva Drug Delivery, L.P. - June 13, 2008

Meridian Medical Technologies Inc., a sterile human drug manufacturer in Brentwood, MO, was inspected from June 2-13, 2008. The inspection revealed significant issues including inadequate testing for objectionable microorganisms in sterile products, poor facility maintenance with contamination risks in aseptic areas, and a failure to follow complaint handling procedures. These observations indicate serious deficiencies in quality control and aseptic processing.