FDA 483 - ACS Dobfar S.p.A. - July 04, 2022

An FDA inspection of ACS Dobfar S.p.A. in Tribiano, Milano, Italy, conducted from July 4-8, 2022, revealed significant deficiencies in record-keeping practices. Observations included incomplete batch and laboratory control records, as well as a lack of independent verification for the accuracy of original laboratory data. These issues indicate potential concerns with data integrity and quality control within the facility.