Company
United StatesShionogi Inc., Alpharetta, GA – FDA Inspections
Inspection records and compliance data for Shionogi Inc. in Alpharetta, Georgia. 8 FDA inspections on record, last inspected February 15, 2018.
Company Profile
This profile covers Shionogi Inc. based in Alpharetta, Georgia, United States.
FDA Inspection History
- FDA inspections
- 8
- OAI
- 0
- VAI
- 4
- NAI
- 4
- Form 483s
- 0
- Warning letters
- 0
First inspected January 15, 2009. Last inspected February 15, 2018.
Most cited issue areas
- Approval and review of procedures2 inspections
- Investigations of discrepancies, failures2 inspections
- Procedures not in writing, fully followed2 inspections
FDA inspections (8)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| February 15, 2018 | NAI | Human Drugs · Drug Quality Assurance | 1044405 |
| February 2, 2015 | VAI | Human Drugs · Drug Quality Assurance | 912412 |
| May 16, 2013 | VAI | Human Drugs · Drug Quality Assurance | 832707 |
| February 8, 2012 | NAI | Human Drugs, Medical Devices & Rad Health · Compliance: Devices | 766562 |
| July 9, 2010 | NAI | Human Drugs · Drug Quality Assurance | 681164 |
| July 9, 2010 | VAI | Human Drugs, Medical Devices & Rad Health · Drug Quality Assurance | 674381 |
| January 15, 2009 | NAI | Human Drugs · Drug Quality Assurance | 557723 |
| January 15, 2009 | VAI | Human Drugs · Drug Quality Assurance | 557715 |
FDA documents
No Form 483s, Warning Letters or EIRs on record.
Related Companies (10)
Companies with similar regulatory profiles, compliance history, and operations.
Company Information
Name
Shionogi Inc.
FEI Number
3004530896
Address
5770 Shiloh Rd, Alpharetta, Georgia 30005, United States
Country
United States
ID: 722eecd3-2e54-40aa-84f9-e38aa1d392aa