SGS North America Inc. – FDA EIR, Jul 30, 2017

An FDA routine surveillance inspection of SGS Life Sciences Services in Fairfield, NJ, was conducted from August 28 to August 30, 2017. This comprehensive cGMP inspection, performed under Compliance Program 7356.002, focused on quality, laboratory, materials, and equipment/facilities systems for this control testing laboratory. While no formal FDA Form 483 inspectional observations were issued, the inspection identified several areas requiring improvement. Key issues discussed with management included deficiencies in employee training records, particularly for the Microbiology Manager, such as missing quizzes and lack of reviewer signatures. The change control procedure was found to lack sufficient justification and clarity. Significant concerns were raised regarding Out-of-Specification (OOS) investigations, specifically the practice of performing initial hypothesis testing on expired solutions and the generic nature of root cause analysis documentation. Furthermore, the inspection revealed inadequate documentation and untimely review of various logbooks, including incubator usage, HPLC equipment logs, and autoclave kill cycles, leading to missed deviations like environmental monitoring excursions. Management acknowledged these concerns, committing to implement corrective actions such as updating training records and systems, revising change control and OOS investigation procedures, ensuring timely logbook documentation and review, and addressing the root causes of identified deficiencies to maintain compliance with current good manufacturing practices.