Company
JapanSekisui Medical Co., Ltd., Hachimantai, Japan – FDA Inspections
Inspection records and compliance data for Sekisui Medical Co., Ltd. in Hachimantai. 5 FDA inspections on record (1 OAI), 1 Form 483, last inspected November 21, 2025.
Company Profile
This profile covers Sekisui Medical Co., Ltd. based in Hachimantai, Japan.
FDA Inspection History
- FDA inspections
- 5
- OAI
- 1
- VAI
- 0
- NAI
- 3
- Unclassified
- 1
- Form 483s
- 1
- Warning letters
- 0
First inspected October 27, 2011. Last inspected November 21, 2025.
FDA inspections (5)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| November 21, 2025 | Not classified | Human Drugs | 1297890 |
| March 8, 2019 | NAI | Human Drugs · Drug Quality Assurance | 1085997 |
| July 27, 2017 | NAI | Human Drugs · Drug Quality Assurance | 1025783 |
| June 17, 2016 | OAI | Human Drugs · Drug Quality Assurance | 975168 |
| October 27, 2011 | NAI | Human Drugs · Drug Quality Assurance | 754938 |
FDA documents
Related Companies (10)
Companies with similar regulatory profiles, compliance history, and operations.
Elementis SRL, Inc.
GE Healthcare AS, Lindesnes Site
ST Pharm Co., Ltd.
Dr. Reddy's Laboratories Ltd
Elementis Specialties (India) Private Limited
Dr. Reddy's Laboratories Limited (Unit II)
Dr. Reddy's Laboratories (EU) Ltd.
Dr. Reddy's Laboratories Limited (Chemical Tech Ops - III)
Gland Pharma Limited
Dr. Reddy's Laboratories Ltd, CTO Unit 1
Company Information
Name
Sekisui Medical Co., Ltd.
FEI Number
3002806840
Address
Dai 4 Chiwari 115, Matsuo, Hachimantai, Japan
Country
Japan
ID: 4dfadeea-0d4e-4543-9dfe-d210f0a51125