Company
United StatesSunstar Americas, Inc., Schaumburg, IL – FDA Inspections
Inspection records and compliance data for Sunstar Americas, Inc. in Schaumburg, Illinois. 7 FDA inspections on record (1 OAI), 1 Form 483, 1 warning letter, last inspected February 10, 2023.
Company Profile
This profile covers Sunstar Americas, Inc. based in Schaumburg, Illinois, United States.
FDA Inspection History
- FDA inspections
- 7
- OAI
- 1
- VAI
- 1
- NAI
- 5
- Form 483s
- 1
- Warning letters
- 1
First inspected October 27, 2011. Last inspected February 10, 2023.
Most cited issue areas
- Lack of or inadequate procedures1 inspection
FDA inspections (7)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| February 10, 2023 | VAI | Medical Devices & Rad Health · Compliance: Devices | 1199742 |
| February 18, 2021 | OAI | Human Drugs, Medical Devices & Rad Health · Drug Quality Assurance | 1135892 |
| June 6, 2016 | NAI | Biologics · Human Cellular, Tissue, and Gene Therapies | 985191 |
| December 16, 2014 | NAI | Medical Devices & Rad Health · Compliance: Devices | 907857 |
| December 3, 2013 | NAI | Biologics · Human Cellular, Tissue, and Gene Therapies | 857393 |
| December 20, 2011 | NAI | Human Drugs · Drug Quality Assurance | 759343 |
| October 27, 2011 | NAI | Medical Devices & Rad Health · Compliance: Devices | 765530 |
FDA documents
Warning Letters (1)
People (5)
Related Companies (10)
Companies with similar regulatory profiles, compliance history, and operations.
Company Information
Name
Sunstar Americas, Inc.
FEI Number
1413787
Address
301 E Central Rd, Schaumburg, Illinois 60195, United States
Country
United States
ID: 0ec42537-1ebf-49da-8ac8-507cd57e020a