FDA 483 - Alk-abello A/s - November 18, 2019

ALK-Abello A/S, a licensed biological manufacturer in Horsholm, Denmark, was cited for significant deficiencies in quality control, data integrity, and environmental monitoring during an FDA inspection. Observations included unsuitable statistical procedures for drug substance specifications, lack of appropriate acceptance levels for quality control, and failure to follow written procedures for data protection and aseptic technique. The firm also failed to ensure second-person review for all microbial enumeration results and lacked supporting data for its environmental monitoring incubation procedures.