FDA EIR - Apex Healthcare Limited - June 15, 2023

A comprehensive surveillance inspection of Apex Healthcare Limited, an Active Pharmaceutical Ingredient (API) manufacturer, was conducted by the FDA from June 12 to June 15, 2023. This was the firm's first FDA inspection, carried out under compliance program 7356.002 for Drug Manufacturing Inspections. At the inspection's conclusion, a Form FDA 483 was issued, detailing three main observations. These included an inadequate written procedure for the review of laboratory control records, insufficient controls in computerized systems to prevent data loss, and the lack of an established procedure for label reconciliation. Additionally, two deficiencies were verbally discussed with firm management: an undefined setup for the firm's balance printer and inconsistent recording in Stability Chamber Opening Registers. The inspection was classified as Voluntary Action Indicated (VAI), meaning Apex Healthcare Limited is expected to voluntarily implement corrective actions to address these findings and ensure compliance with drug manufacturing regulations.