FDA 483 - ARSCI INC. - October 30, 2014

Jieying Laboratory Inc. in Longueuil, Quebec, Canada, was inspected by the FDA from October 27-30, 2014. The inspection revealed significant deficiencies across its quality system, particularly concerning the lack of established procedures for design control, process validation, acceptance activities, change control, device master records, device history records, equipment calibration, sampling methods, CAPA, labeling, nonconforming product, complaint handling, quality audits, and employee training. These widespread issues indicate a severely underdeveloped quality management system for a manufacturer of products used in in-vitro fertility procedures.