FDA 483 - Zoetis, LLC - January 09, 2017

An FDA inspection of Zoetis LLC in Willow Island, WV, an API and Type A Medicated Articles manufacturer, revealed four observations. The firm failed to thoroughly review unexplained discrepancies, lacked appropriate controls over computer systems, and did not have established procedures for QC laboratory equipment maintenance. Additionally, active pharmaceutical ingredients and medicated articles were not stored under controlled conditions consistent with product labels.