# Samsung Biologics Co., Ltd., Yeonsu-gu, Korea (the Republic of) – FDA Inspections Source: https://www.keypedia.com/companies/samsung-biologics-co-ltd/817b7bc4-2de1-47f4-b552-178303c8da01 > Inspection records and compliance data for Samsung Biologics Co., Ltd. in Yeonsu-gu. 10 FDA inspections on record, 9 Form 483s, last inspected May 27, 2025. --- ## Details - Name: Samsung Biologics Co., Ltd. - FEI Number: 3010479596 - Address Line 1: 300 - Address Line 2: Songdo Bio-Daero - City: Yeonsu-gu - Country Name: Korea (the Republic of) - Address: 300 Songdo Bio-Daero, Yeonsu-gu, Korea (the Republic of) - Country: Korea (the Republic of) ## Related Documents - [483 - Samsung Biologics Co., Ltd. - Unknown Date](https://www.keypedia.com/records/483/samsung-biologics-co-ltd/debf9a32-caae-458a-b745-278d78c83877) — source: FDA, date: Invalid Date - [483 - Samsung Biologics Co., Ltd. - Unknown Date](https://www.keypedia.com/records/483/samsung-biologics-co-ltd/e6eee8b1-6875-48d5-b66c-78c440f4dc88) — source: FDA, date: Invalid Date - [483 - Samsung Biologics Co., Ltd. - Unknown Date](https://www.keypedia.com/records/483/samsung-biologics-co-ltd/f77a8fa0-5e1a-49af-b52c-92b0e5e25865) — source: FDA, date: Invalid Date - [483 - Samsung Biologics Co., Ltd. - 2025-05-27](https://www.keypedia.com/records/483/samsung-biologics-co-ltd/b3a6afca-acc1-42d3-9eaa-a9c039d1bb0a) — source: FDA, date: May 27, 2025 - [FDA Inspection 1269570 - Samsung Biologics Co., Ltd. - 2025-05-27](https://www.keypedia.com/records/fda_inspections/samsung-biologics-co-ltd/d20015df-a132-4e1e-be47-84e8a2b9ad6f) — source: FDA, date: May 27, 2025 - [483 - Samsung Biologics Co., Ltd. - 2024-07-30](https://www.keypedia.com/records/483/samsung-biologics-co-ltd/6e40e6e0-81d7-4a42-b6e2-13cc55efe248) — source: FDA, date: July 30, 2024 - [EIR - Samsung Biologics Co., Ltd. - 2024-07-30](https://www.keypedia.com/records/eir/samsung-biologics-co-ltd/033a5fa8-b6a6-4d39-85d9-01bb91ffa2e1) — source: FDA, date: July 30, 2024 - [FDA Inspection 1261652 - Samsung Biologics Co., Ltd. - 2024-07-30](https://www.keypedia.com/records/fda_inspections/samsung-biologics-co-ltd/29457fce-fda9-42c5-87a5-8c153abd9d3a) — source: FDA, date: July 30, 2024 - [483 - Samsung Biologics Co., Ltd. - 2023-09-01](https://www.keypedia.com/records/483/samsung-biologics-co-ltd/9bb101f9-4ffa-4d6d-befb-21f482837c80) — source: FDA, date: September 1, 2023 - [FDA Inspection 1218067 - Samsung Biologics Co., Ltd. - 2023-09-01](https://www.keypedia.com/records/fda_inspections/samsung-biologics-co-ltd/4f09b686-db97-4bd1-85fb-2ebcd9a54f72) — classification: Voluntary Action Indicated (VAI), source: FDA, date: September 1, 2023 - [FDA Inspection 1201856 - Samsung Biologics Co., Ltd. - 2023-02-28](https://www.keypedia.com/records/fda_inspections/samsung-biologics-co-ltd/769da2e8-0f45-4a78-ae4e-7e9cefc4d32f) — classification: Voluntary Action Indicated (VAI), source: FDA, date: February 28, 2023 - [483 - Samsung Biologics Co., Ltd. - 2023-02-20](https://www.keypedia.com/records/483/samsung-biologics-co-ltd/ddfd6afc-35be-427a-aeee-027047c73e7d) — source: FDA, date: February 20, 2023 - [483 - Samsung Biologics Co., Ltd. - 2022-06-09](https://www.keypedia.com/records/483/samsung-biologics-co-ltd/caf2bc64-dcd8-4d80-a40d-ca04258e6266) — source: FDA, date: June 9, 2022 - [483 - Samsung Biologics Co., Ltd. - 2021-08-24](https://www.keypedia.com/records/483/samsung-biologics-co-ltd/1438e64e-df97-414c-bdce-bd6137243e90) — source: FDA, date: August 24, 2021 - [FDA Inspection 1108244 - Samsung Biologics Co., Ltd. - 2019-11-01](https://www.keypedia.com/records/fda_inspections/samsung-biologics-co-ltd/7097d01b-422a-4c04-aabf-43ae536c0e32) — classification: Voluntary Action Indicated (VAI), source: FDA, date: November 1, 2019 - [FDA Inspection 1105813 - Samsung Biologics Co., Ltd. - 2019-09-10](https://www.keypedia.com/records/fda_inspections/samsung-biologics-co-ltd/ae840f8a-dcab-4a93-8426-9c924e668383) — source: FDA, date: September 10, 2019 - FDA Inspection 1056899 - Samsung Biologics Co., Ltd. - 2018-06-26 — classification: Voluntary Action Indicated (VAI), source: FDA, date: June 26, 2018 - [FDA Inspection 1056899 - Samsung Biologics Co., Ltd. - 2018-06-26](https://www.keypedia.com/records/fda_inspections/samsung-biologics-co-ltd/3f506971-1c3a-4a46-87c6-4997cb368f5a) — classification: Voluntary Action Indicated (VAI), source: FDA, date: June 26, 2018 - [FDA Inspection 1052792 - Samsung Biologics Co., Ltd. - 2018-05-11](https://www.keypedia.com/records/fda_inspections/samsung-biologics-co-ltd/acddc852-7b28-4a79-b1b2-3b7c2fd63e1d) — source: FDA, date: May 11, 2018 - [FDA Inspection 1046813 - Samsung Biologics Co., Ltd. - 2018-03-14](https://www.keypedia.com/records/fda_inspections/samsung-biologics-co-ltd/2a781f9e-0bbf-467c-b957-087680264ad8) — source: FDA, date: March 14, 2018 ## Related Companies - [Shanghai Henlius Biologics Co., Ltd.](https://www.keypedia.com/companies/shanghai-henlius-biologics-co-ltd/ca560713-8df4-4bed-a460-7157ef410918) - [Hugel Inc.](https://www.keypedia.com/companies/hugel-inc/c3f52dc8-7334-454e-b30b-24a21c659c7d) - [Bio-Thera Solutions, Ltd.](https://www.keypedia.com/companies/bio-thera-solutions-ltd/a06cd8e7-9627-48bf-9f70-d2458bdc560b) - [Biocon Sdn. Bhd. (Company No. 201101002193)](https://www.keypedia.com/companies/biocon-sdn-bhd-company-no-201101002193/b7eb03f4-676c-44c0-af88-528fbc4236a8) - [Advanced Accelerator Applications USA, Inc.](https://www.keypedia.com/companies/advanced-accelerator-applications-usa-inc/ccfc70b0-8949-4d64-8e92-b725c1f0d81f) - [STgen Bio Co., Ltd.](https://www.keypedia.com/companies/stgen-bio-co-ltd/bf0530c2-b747-4fce-ade6-52850415aac3) - [Celltrion Inc.](https://www.keypedia.com/companies/celltrion-inc/d3991ec8-423b-4554-9d67-72bc27a8658b) - [Novartis Manufacturing LLC](https://www.keypedia.com/companies/novartis-manufacturing-llc/c4165663-ccb2-4abd-bba3-af6a0bdf462d) - [Alvotech HF](https://www.keypedia.com/companies/alvotech-hf/68dcb740-c89d-4dbc-934a-d8c7ccd414ab) - [Patheon Biologics Australia Pty Ltd](https://www.keypedia.com/companies/patheon-biologics-australia-pty-ltd/ede6b641-a0a7-4b0b-918b-f09c3b1d060b) ## Related Officers - [Jiaxin Chun](https://www.keypedia.com/people/jiaxin-chun/0a784d7e-3b51-496c-bf5c-4dc50ba8189c) - [Peng Zhou](https://www.keypedia.com/people/peng-zhou/ce413ab5-8787-4012-bc8f-9ef55f2c3dc1) - [ Investigator, Consumer Safety Officer](https://www.keypedia.com/people/thuy-t-nguyen/1cfb5467-f0b7-49b8-85c1-00373692e35e) - [investigator](https://www.keypedia.com/people/riley-myers/22266738-1313-45db-902d-eaf4c63d4131) - [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)