# FDA 483 - Samsung Biologics Co., Ltd. - Unknown Date

Source: https://www.keypedia.com/records/483/samsung-biologics-co-ltd/f77a8fa0-5e1a-49af-b52c-92b0e5e25865

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

---

## Details

- Record Type: 483
- Company Name: Samsung Biologics Co., Ltd.
- Product Type: drugs
- Office Name: Office of Biological Products Operations - Division I
- Summary: An FDA inspection of Samsung Biologics Co., Ltd. in Incheon, Korea, revealed significant deficiencies across multiple areas of their drug manufacturing operations. Key issues included inadequate data integrity controls in the MSAT laboratory, failures to follow written procedures for aseptic processing, and a deficient Quality Unit. The inspection also cited problems with equipment revalidation and facility maintenance, indicating a broad scope of non-compliance.

## Related Documents

- [483 - 2025-05-27](https://www.keypedia.com/records/483/samsung-biologics-co-ltd/b3a6afca-acc1-42d3-9eaa-a9c039d1bb0a)
- [483 - 2022-06-09](https://www.keypedia.com/records/483/samsung-biologics-co-ltd/134cfe7e-fea2-4b96-9e87-ef42c2597d55)
- [483 - 2021-08-24](https://www.keypedia.com/records/483/samsung-biologics-co-ltd/f660cf8a-50b8-4766-b37d-4605324fd16b)
- [483 - 2022-06-09](https://www.keypedia.com/records/483/samsung-biologics-co-ltd/caf2bc64-dcd8-4d80-a40d-ca04258e6266)
- [483 - 2018-03-14](https://www.keypedia.com/records/483/samsung-biologics-co-ltd/ce260ba9-5da0-4986-9b6e-3fee4fc334d5)

## Related Officers

- [Hyunjong Lee](https://www.keypedia.com/people/hyunjong-lee/1b7b64fb-eec0-418a-a090-cdc9a42cd9e6)
- [Dongdo D. Mckenzie](https://www.keypedia.com/people/dongdo-d-mckenzie/721236ea-cfed-47ed-8da2-fb5baab477fa)
- [Jiyun S. Oh](https://www.keypedia.com/people/jiyun-s-oh/fc1b0b3e-f11a-42d0-8d2e-32367a32206c)

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