FDA 483 - SGS Life Sciences Services - December 12, 2017

SGS Canada Inc., Life Science Services, a contract laboratory in Mississauga, Ontario, was cited for significant quality control deficiencies during an FDA inspection. The firm failed to thoroughly investigate out-of-specification (OOS) results, often canceling investigations or classifying root causes as "unassignable" based on client requests or payment. Additionally, the inspection revealed the firm's practice of using expired reference standards for analytical testing, directly violating its own procedures and compromising the validity of test results.