SGS North America Inc. – FDA 483, Aug 1, 2023

SGS North America Inc. in Fairfield, NJ, a control testing laboratory, was cited with two observations during an FDA inspection. The inspection revealed significant issues with data integrity and quality control, including the use of unvalidated Excel spreadsheets for critical analytical data calculations and failures in documenting data review and error corrections. These deficiencies indicate a lack of robust control over computer systems and the quality unit's procedures.