FDA EIR - SGS Life Sciences Services - July 20, 2012

SGS Life Science Services, a contract testing laboratory located in Mississauga, Canada, underwent an FDA inspection from July 19-20, 2012. The inspection aimed to assess compliance with Good Manufacturing Practices (GMP) and evaluate the firm's quality and laboratory systems, including verifying corrections from a previous inspection. The FDA issued an Inspectional Observation (Form FDA-483) to the company's Business Manager, Mr. Michael Lindsay, detailing key issues. The primary violation identified was a lack of assurance regarding the authenticity of laboratory notebook pages submitted for review; analysts manually entered book numbers on removable pages, creating a data integrity risk. Additionally, discussions highlighted an insufficient investigation into a deviation related to LIMS user assignment privileges, a failure of data reviewers to review electronic chromatography data audit trails (only printed chromatograms were reviewed), and system suitability requirements in client methods that did not meet current USP standards. The company committed to implementing necessary corrections and providing a written response to the FDA within 15 days.