# FDA 483 - Samsung Biologics Co., Ltd. - June 26, 2018

Source: https://www.keypedia.com/records/483/samsung-biologics-co-ltd/f30ce007-aebc-4adb-b5d0-3fe2fcb25da0

> FDA 483 for Samsung Biologics Co., Ltd. on June 26, 2018. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Samsung Biologics Co., Ltd.
- Inspection Date: 2018-06-26
- Product Type: drugs
- Office Name: Office of Biological Products Operations - Division I
- Summary: An FDA inspection of Samsung Biologics Co. Ltd. in Yeonsu, Incheon, a sterile drug manufacturer, revealed significant deficiencies across three observations. The firm was cited for inadequate training of visual inspectors, issues with equipment design and calibration records, and insufficient detail in cleaning and maintenance procedures for critical surfaces. These findings indicate a need for improved quality control and adherence to good manufacturing practices.

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## Related Officers

- [National Program Expert- Pharmacy Compounding](https://www.keypedia.com/people/lucila-b-nwatu/3d1c9670-8206-425c-bddd-32e395293042)
- [Deborah H. Schmiel](https://www.keypedia.com/people/deborah-h-schmiel/facfc308-52af-4353-902a-0d45d5d88020)

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