Company
JapanDaiichi Sankyo Co., Ltd. Hiratsuka Plant, Hiratsuka, Japan – FDA Inspections
Inspection records and compliance data for Daiichi Sankyo Co., Ltd. Hiratsuka Plant in Hiratsuka. 4 FDA inspections on record, 1 Form 483, last inspected August 29, 2019.
Company Profile
This profile covers Daiichi Sankyo Co., Ltd. Hiratsuka Plant based in Hiratsuka, Japan.
FDA Inspection History
- FDA inspections
- 4
- OAI
- 0
- VAI
- 3
- NAI
- 1
- Form 483s
- 1
- Warning letters
- 0
First inspected June 13, 2014. Last inspected August 29, 2019.
Most cited issue areas
- Following/documenting laboratory controls1 inspection
- Procedures not in writing, fully followed1 inspection
- Written record of investigation incomplete1 inspection
FDA inspections (4)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| August 29, 2019 | NAI | Human Drugs · Drug Quality Assurance | 1105205 |
| November 2, 2017 | VAI | Human Drugs · Drug Quality Assurance | 1032011 |
| April 22, 2016 | VAI | Human Drugs · Drug Quality Assurance | 971651 |
| June 13, 2014 | VAI | Human Drugs · Drug Quality Assurance | 888923 |
FDA documents
Form 483s (1)
Other regulators (1)
- Health Canada · 5 inspections · last August 26, 2019
People (2)
Related Companies (10)
Companies with similar regulatory profiles, compliance history, and operations.
Company Information
Name
Daiichi Sankyo Co., Ltd. Hiratsuka Plant
FEI Number
3002808070
Address
1 Chome 12-1, Shinomiya, Hiratsuka, Japan
Country
Japan
ID: d9bb5238-4acc-4fc5-8638-db754e816be8