SOCIETAL CDMO SAN DIEGO, LLC – FDA EIR, Apr 7, 2021

An FDA pre-approval and quality system inspection of Irisys, LLC, a contract manufacturer of human drugs and combination drug/device products, was conducted from March 30 to April 7, 2021, in San Diego, CA. The inspection assessed the company's readiness for commercial manufacturing, adherence to application standards, and data integrity under the Food, Drug, and Cosmetic Act and current Good Manufacturing Practice (cGMP) regulations.

The inspection resulted in a five-item FDA Form 483, detailing several deficiencies. Key issues included the quality control unit failing to review and approve drug product production records before batch release for validation batches. Repeat observations from a prior 2018 inspection highlighted inadequate routine calibration and maintenance programs for automatic and electronic equipment, and deficiencies in validating component supplier analysis reports, specifically for oxygen. Additionally, the inspection found insufficient controls over computer systems to ensure only authorized personnel institute changes in critical records, and a lack of written investigations for unexplained discrepancies, such as foreign material in a reserve sample. Irisys, LLC, committed to correcting each deficiency and is expected to submit a written response to the FDA within fifteen business days.