FDA 483 - Aphena Pharma Solutions-Maryland LLC - May 06, 2022

Aphena Pharma Solutions-Maryland LLC in Easton, MD, was cited for significant deficiencies during an FDA inspection. Observations included inadequate equipment qualification for a blend tank, failures to thoroughly investigate unexplained discrepancies in batch records, and incomplete master production and control records. These issues indicate a lack of robust quality control and process validation in drug product manufacturing.