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

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

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Record Details

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.

Company: Meridian Medical Technologies, LLC a Subsidiary of Kindeva Drug Delivery, L.P.
Inspection Date: June 13, 2008
Product Type: Drugs
Office: Kansas City District Office
People: Veronica L. Call
Shirley J. Berryman (Owner)
Kara L. Roden

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ID · 48873837-e629-4100-bb16-9bc121018364