# FDA 483 - SGS-CSTC Standards Technical Services (Shanghai) Co., Ltd. - March 23, 2019

Source: https://www.keypedia.com/records/483/sgs-cstc-standards-technical-services-shanghai-co-ltd/6195bfe7-38f1-429e-afbf-de542b291f49

> FDA 483 for SGS-CSTC Standards Technical Services (Shanghai) Co., Ltd. on March 23, 2019. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: SGS-CSTC Standards Technical Services (Shanghai) Co., Ltd.
- Inspection Date: 2019-03-23
- Product Type: drugs
- Office Name: Office of Biological Products Operations - Division I
- Summary: The FDA inspection of SGS-CSTC Standards Technical Services Co., Ltd. in Shanghai, a contract testing laboratory, revealed significant deficiencies in their quality control systems. The firm failed to adequately investigate out-of-specification (OOS) results and deviations, often invalidating results without scientific justification or leaving investigations incomplete. Furthermore, the accuracy, sensitivity, specificity, and reproducibility of their test methods were not properly established and documented.

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Company: https://www.keypedia.com/companies/sgs-cstc-standards-technical-services-shanghai-co-ltd/bcec08f1-6804-46e6-b00e-a89cf8512b0f

Office: https://www.keypedia.com/offices/office-of-biological-products-operations-division-i/49c53dac-7724-4c8c-8708-4f5779ea69c1