# FDA 483 - Samsung Biologics Co., Ltd. - November 01, 2019

Source: https://www.keypedia.com/records/483/samsung-biologics-co-ltd/1d997c69-57a4-460b-a2c0-85acb578f22f

> FDA 483 for Samsung Biologics Co., Ltd. on November 01, 2019. Product: biologics. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Samsung Biologics Co., Ltd.
- Inspection Date: 2019-11-01
- Product Type: biologics
- Office Name: Office of Biological Products Operations - Division I
- Summary: An FDA inspection of Samsung Biologics Co. Ltd., a sterile pharmaceutical manufacturer in Incheon, Korea, revealed significant deficiencies in their quality system. The firm failed to properly record and justify deviations from written production and process control procedures. Specifically, "GMP Incidents" were closed without adequate investigation or corrective actions, and the system for identifying reoccurring deviations was found to be insufficient.

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## Related Officers

- [ Investigator ](https://www.keypedia.com/people/matthew-b-casale/e78481c6-5fbd-4723-a79c-167176395af8)

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

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