FDA 483 - SOCIETAL CDMO SAN DIEGO, LLC - April 07, 2021

Irieys, LLC, a drug product manufacturer in San Diego, CA, was inspected and received a Form 483 with five observations, including repeat issues. The inspection revealed significant deficiencies in quality control unit review of batch records, equipment calibration and maintenance, supplier qualification, computer system controls, and investigation of unexplained discrepancies. These findings indicate a lack of robust quality system oversight and control over critical manufacturing and laboratory operations.