FDA 483 - Micro-Macinazione SA - May 31, 2019

Micro-Macinazione SA, a drug manufacturer in Monteggio, Switzerland, was cited for two significant issues during an FDA inspection. The firm's investigations into drug substance quality complaints were found to be inadequate, failing to assess the full scope of affected products and processes. Additionally, non-dedicated production equipment was not maintained in a good state of repair, posing a risk of cross-contamination of active pharmaceutical ingredients.