FDA 483 - Meridian Medical Technologies, LLC a Subsidiary of Kindeva Drug Delivery, L.P. - February 13, 2012

The FDA Form 483 details multiple violations at a facility manufacturing Multichambered AutoInjectors (e.g., Atropine/Pralidoxime Chloride).

**Production and Process Control Deficiencies:** * **Batch 1M1726:** Production and process control procedures were not followed. * Raw data from 100% inspection for plunger placement rework was not documented; only final results were recorded. * Rework was not reviewed or approved by the Quality Unit. * Weight verification for container counts was not documented. * **Product Transfer:** SOP-MDP-GEN-00013-SL was not followed for Atropine batch 1M1726; the transfer form indicated a different transfer date than the carrier's sign-off. * **Annual Review:** Annual review of AtroPen product reserves was not approved by the statistical quality control supervisor by the due date of 3/31/2011, as required by SOP-QLC-SQC-00384-SL. Approval occurred on 6/27/2011.

**Aseptic Processing and Microbiological Contamination Control Issues:** * **SOP-PRO-FIL-00001-SL (General Aseptic Procedure) Not Followed:** * Operator was observed