FDA 483 - Almac Pharma Services LLC - February 03, 2022

An FDA inspection of Almac Pharma Services LLC in Audubon, PA, a drug packager and labeler, revealed two significant issues. The firm failed to thoroughly investigate unexplained discrepancies, specifically incidents where gel caps were sliced open and spilled during the blister packing process. Additionally, the inspection found that deviations from written production and process control procedures were not justified, particularly concerning recurring water leaks into production rooms from the facility's roof.