# Sumitomo Dainippon Pharma Co., Ltd., Oita, Japan – FDA Inspections

Source: https://www.keypedia.com/companies/sumitomo-dainippon-pharma-co-ltd/a14dd605-ff5f-4e7a-a71b-73f6eb72a9c6

> Inspection records and compliance data for Sumitomo Dainippon Pharma Co., Ltd. in Oita. 6 FDA inspections on record, 3 Form 483s, last inspected July 11, 2025.

---

## Details

- Name: Sumitomo Dainippon Pharma Co., Ltd.
- FEI Number: 3005619533
- Address Line 1: 2200, Oazatsurusaki
- City: Oita
- Country Name: Japan
- Address: 2200, Oazatsurusaki, Oita, Japan
- Country: Japan

## Related Documents

- [483 - Sumitomo Dainippon Pharma Co., Ltd. - 2025-07-11](https://www.keypedia.com/records/483/sumitomo-dainippon-pharma-co-ltd/0656e3d5-d284-4aa6-a7e2-95f9bddcde4d) — source: FDA, date: July 11, 2025
- [FDA Inspection 1276963 - Sumitomo Dainippon Pharma Co., Ltd. - 2025-07-11](https://www.keypedia.com/records/fda_inspections/sumitomo-dainippon-pharma-co-ltd/959cb516-78a7-4b4f-96f4-d510481d7ed0) — classification: Voluntary Action Indicated (VAI), source: FDA, date: July 11, 2025
- [483 - Sumitomo Dainippon Pharma Co., Ltd. - 2019-04-16](https://www.keypedia.com/records/483/sumitomo-dainippon-pharma-co-ltd/673ad617-6525-4220-b21a-6475356ffdb9) — source: FDA, date: April 16, 2019
- [FDA Inspection 1088923 - Sumitomo Dainippon Pharma Co., Ltd. - 2019-04-16](https://www.keypedia.com/records/fda_inspections/sumitomo-dainippon-pharma-co-ltd/7a4e397a-ac18-4bee-996b-e502e1b4dad2) — classification: Voluntary Action Indicated (VAI), source: FDA, date: April 16, 2019
- [FDA Inspection 1003840 - Sumitomo Dainippon Pharma Co., Ltd. - 2017-02-17](https://www.keypedia.com/records/fda_inspections/sumitomo-dainippon-pharma-co-ltd/5bae5b31-f273-4048-9552-f3d2683edd30) — classification: Voluntary Action Indicated (VAI), source: FDA, date: February 17, 2017
- FDA Inspection 895955 - Sumitomo Dainippon Pharma Co., Ltd. - 2014-09-12 — classification: Voluntary Action Indicated (VAI), source: FDA, date: September 12, 2014
- FDA Inspection 797370 - Sumitomo Dainippon Pharma Co., Ltd. - 2012-02-24 — classification: Voluntary Action Indicated (VAI), source: FDA, date: February 24, 2012
- FDA Inspection 676813 - Sumitomo Dainippon Pharma Co., Ltd. - 2010-07-30 — classification: Voluntary Action Indicated (VAI), source: FDA, date: July 30, 2010

## Related Companies

- [Forces of Nature, Inc.](https://www.keypedia.com/companies/forces-of-nature-inc/0cdf818b-b6c2-4d3d-9398-563b8252c239)
- [Takeda Ireland Ltd](https://www.keypedia.com/companies/takeda-ireland-ltd/88620821-e6b8-454b-ac4f-4729be466d67)
- [Xttrium Laboratories, Inc.](https://www.keypedia.com/companies/xttrium-laboratories-inc/30da7793-2a5c-4bf5-814c-05fc0921d353)
- [Shanghai Henlius Biopharmaceuticals Co., Ltd.](https://www.keypedia.com/companies/shanghai-henlius-biopharmaceuticals-co-ltd/27f2ead3-2366-4479-aa2e-d9895581080b)
- [Advanced Accelerator Applications (Italy) srl](https://www.keypedia.com/companies/advanced-accelerator-applications-italy-srl/09ac059c-6735-4082-8674-a88476dbdbc6)
- [Suzhou Union Biopharm Co., Ltd.](https://www.keypedia.com/companies/suzhou-union-biopharm-co-ltd/5d9c9c07-1afc-44da-b4ff-872317d01143)
- [Daewoong Pharmaceutical Co. Ltd. (Hyangnam factory)](https://www.keypedia.com/companies/daewoong-pharmaceutical-co-ltd-hyangnam-factory/2f9e6a6a-9f69-4377-b1ef-5500338ce477)
- [Anhui Poly Pharm. Co., Ltd.](https://www.keypedia.com/companies/anhui-poly-pharm-co-ltd/e1d9c61f-37b4-4759-8c00-51c6d0b78d3b)
- [Nordmark Arzneimittel GMBH & Co. KG](https://www.keypedia.com/companies/nordmark-arzneimittel-gmbh-co-kg/871eb270-8517-4646-923a-b4d2eb0ea73b)
- [ALK-Abello, Inc.](https://www.keypedia.com/companies/alk-abello-inc/b626f86d-b379-45aa-96d2-0661e9d1c981)

## Related Officers

- [Principal Consultant](https://www.keypedia.com/people/zhongren-wu/416f09a6-f225-4d23-a305-34f96a5c78f0)
- [SVP Consulting & Operations](https://www.keypedia.com/people/linda-f-murphy/a8b9737f-d5f4-4a36-8684-2fb050d008f2)
- [Consumer Safety Officer ](https://www.keypedia.com/people/anastasia-m-shields/a22b8d52-e3f9-4e61-aa3f-6f03ff2f59df)
- [Drug Investigator](https://www.keypedia.com/people/jessica-s-estriplet/b7152ec3-6e1b-45aa-840e-7147f357aea2)