# Samsung Biologics Co., Ltd. – FDA 483

Source: https://www.keypedia.com/records/483/samsung-biologics-co-ltd/debf9a32-caae-458a-b745-278d78c83877

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

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## Details

- Record Type: 483
- Company Name: Samsung Biologics Co., Ltd.
- Product Type: drugs
- Office Name: Division of Advertising & Promotion 
- Summary: Samsung Biologics Corporation, Ltd. in Yeonsu-Gu, Incheon, Republic of Korea, was cited with five observations during an FDA inspection. The inspection revealed significant issues related to aseptic processing, including microbial contamination risks, inadequate quality control oversight, failure to record deviations, poor equipment maintenance, and deficiencies in environmental monitoring. These findings indicate a lack of adherence to GMP procedures for sterile drug product manufacturing.

## Related Documents

- [483 - 2025-05-27](https://www.keypedia.com/records/483/samsung-biologics-co-ltd/b3a6afca-acc1-42d3-9eaa-a9c039d1bb0a) — date: May 27, 2025
- [483 - 2024-07-30](https://www.keypedia.com/records/483/samsung-biologics-co-ltd/6e40e6e0-81d7-4a42-b6e2-13cc55efe248) — date: July 30, 2024
- [EIR - 2024-07-30](https://www.keypedia.com/records/eir/samsung-biologics-co-ltd/033a5fa8-b6a6-4d39-85d9-01bb91ffa2e1) — date: July 30, 2024
- [483 - 2023-09-01](https://www.keypedia.com/records/483/samsung-biologics-co-ltd/9bb101f9-4ffa-4d6d-befb-21f482837c80) — date: September 1, 2023
- [483 - 2023-02-20](https://www.keypedia.com/records/483/samsung-biologics-co-ltd/ddfd6afc-35be-427a-aeee-027047c73e7d) — date: February 20, 2023

## Related Officers

- [Virginia A. Carroll](https://www.keypedia.com/people/virginia-a-carroll/180e8c1a-1712-4701-9399-9758573ef8d8)
- [Diane Racicot](https://www.keypedia.com/people/diane-racicot/8482cc5e-5105-4618-813a-1ab200dcdaf8)
- [Investigator](https://www.keypedia.com/people/michael-r-shanks/dd24952b-4309-451e-afe8-f68892cd7bac)

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