Warning letter for Lonza

Lonza has received an FDA warning letter following cGMP violations in the production of Eisai's Ontak at its Hopkinton, MA, facility. Lonza received the letter after failing to address issues raised in inspections during April and May. The FDA cited Lonza for inadequate or lack of an investigation of critical deviations or a failure of a batch to meet its specifications or quality standards; failure to validate analytical test methods used for API for potency testing; and failure of its quality unit to exercise its responsibility to ensure that APIs manufactured are in compliance with CGMP, including meeting established specifications for quality and purity. In-pharma Technologist