# FDA 483 - Samsung Biologics Co., Ltd. - July 25, 2017

Source: https://www.keypedia.com/records/483/samsung-biologics-co-ltd/c6c8d9be-3460-4955-aebd-c5d47eea5727

> FDA 483 for Samsung Biologics Co., Ltd. on July 25, 2017. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Samsung Biologics Co., Ltd.
- Inspection Date: 2017-07-25
- Product Type: drugs
- Office Name: Division of Advertising & Promotion 
- Summary: An FDA inspection of Samsung BioLogics' drug substance manufacturing facility in Yeonsu-gu, Incheon, Korea, revealed significant deficiencies in laboratory controls, deviation investigations, and microbial control. The firm failed to adequately verify test methods, properly investigate deviations, ensure microbial control procedures, and conform to USP-NF standards for critical raw materials. These issues indicate a lack of scientifically sound and appropriate procedures to assure product quality and purity.

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Company: https://www.keypedia.com/companies/samsung-biologics-co-ltd/817b7bc4-2de1-47f4-b552-178303c8da01

Office: https://www.keypedia.com/offices/division-of-advertising-promotion/adcc8282-aca9-4610-955c-e6553c7619b0