Company
JapanChugai Pharma Manufacturing Co. Ltd. - Inspection Records
Inspection records and compliance data for Chugai Pharma Manufacturing Co. Ltd. in Utsunomiya. 7 FDA inspections on record, last inspected April 02, 2024.
Company Profile
This profile covers Chugai Pharma Manufacturing Co. Ltd. based in Utsunomiya, Japan.
FDA Inspection History
- FDA inspections
- 7
- OAI
- 0
- VAI
- 4
- NAI
- 3
- Form 483s
- 0
- Warning letters
- 0
First inspected June 11, 2010. Last inspected April 2, 2024.
Most cited issue areas
- Authority lacking to review records, investigate errors1 inspection
- Calibration/Inspection/Checking not done1 inspection
- Cleaning SOPs/schedules1 inspection
FDA inspections (7)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| April 2, 2024 | VAI | Human Drugs · Drug Quality Assurance | 1236880 |
| September 26, 2019 | VAI | Human Drugs · Drug Quality Assurance | 1103317 |
| November 10, 2017 | VAI | Human Drugs · Drug Quality Assurance | 1031133 |
| March 24, 2015 | NAI | Human Drugs · Drug Quality Assurance | 918526 |
| March 15, 2013 | NAI | Human Drugs · Drug Quality Assurance | 827757 |
| February 1, 2011 | VAI | Human Drugs · Drug Quality Assurance | 709260 |
| June 11, 2010 | NAI | Human Drugs · Drug Quality Assurance | 680162 |
FDA documents
Other regulators (1)
Company Information
Name
Chugai Pharma Manufacturing Co. Ltd.
FEI Number
3006942691
Address
16-3 Utsunomiya Plant, Kiyoharakogyodanchi, Utsunomiya, Japan
Country
Japan
ID: 09ba6515-9227-444c-a24c-a6cb8da9e235