FDA 483 - LabAnalysis Life Science S.R.L.

LabAnalysis S.r.l. in Casanova Lonati, Pavia, Italy, was inspected by the FDA from October 23-27, 2023, and received a Form 483 with two observations. The inspection revealed deficiencies related to the retention of reference listed drug reserve samples and the incomplete documentation of analytical results in study reports submitted to the FDA. These issues indicate concerns with laboratory controls and data integrity in their biopharmaceutical analytical facility.