FDA 483 - Apertus Pharmaceuticals - January 21, 2020

Apertus Pharmaceuticals, a contract drug manufacturer in St. Louis, MO, was cited for significant deficiencies during an FDA inspection. Observations included inadequate laboratory record data integrity, lack of finished product packaging inspection documentation, deficient in-process controls, absence of periodic product review procedures, and failure to calibrate mechanical equipment. These issues indicate a lack of robust quality control and data management practices.