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

Source: https://www.keypedia.com/records/483/sgs-life-sciences-services/df3dd643-a2b0-4f64-87b8-038c8ea5524b

> FDA 483 for SGS Life Sciences Services on December 12, 2017. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: SGS Life Sciences Services
- Inspection Date: 2017-12-12
- Product Type: drugs
- Office Name: International Compliance Team
- Summary: 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.

## Related Documents

- [483 - 2012-07-20](https://www.keypedia.com/records/483/sgs-life-sciences-services/7139c346-5613-4a7b-9e16-5fd3c5126151)

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Company: https://www.keypedia.com/companies/sgs-life-sciences-services/624d5907-33c7-4416-8fe2-18f47fa17765

Office: https://www.keypedia.com/offices/international-compliance-team/f0ce0d89-bf39-46c6-8c42-28138d161321