FDA EIR - SGS North America Inc. - April 24, 2019

An FDA Current Good Manufacturing Practice (CGMP) inspection was conducted at SGS Life Science Services in Lincolnshire, IL, from April 23-24, 2019. The inspection focused on the company's Quality and Laboratory Control Systems, covering human and animal drug and medical device testing, in accordance with Compliance Programs 7371.001 and 7356.002, falling under the regulatory framework of the FD&C Act. The company functions as a control testing laboratory for drug and device manufacturers, performing chemical and microbiological release and stability testing. The inspection concluded without the issuance of an FDA-483, indicating no formal violations. However, two verbal discussion items were communicated to management. These included observed multiple backup failures of metadata from standalone laboratory instruments, raising potential data loss risks, and instances of misplaced investigation records, which could lead to incomplete documentation. Management at SGS Life Science Services acknowledged these observations and committed to promptly correcting both issues. Previous inspections had identified and subsequently corrected issues related to reserve sample retention, drug accountability, and adherence to calibration schedules, demonstrating the company's continuous efforts in compliance.