Company
United StatesSchwabe North America, Inc., Green Bay, WI – FDA Inspections
Inspection records and compliance data for Schwabe North America, Inc. in Green Bay, Wisconsin. 14 FDA inspections on record, 1 Form 483, 1 warning letter, last inspected August 28, 2025.
Company Profile
This profile covers Schwabe North America, Inc. based in Green Bay, Wisconsin, United States.
FDA Inspection History
- FDA inspections
- 14
- OAI
- 0
- VAI
- 5
- NAI
- 9
- Form 483s
- 1
- Warning letters
- 1
First inspected July 17, 2009. Last inspected August 28, 2025.
Most cited issue areas
- Calibration/Inspection/Checking not done2 inspections
- Absence of Written Procedures1 inspection
- Adequate number of batches on stability1 inspection
FDA inspections (14)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| August 28, 2025 | VAI | Human Drugs · Drug Quality Assurance | 1271627 |
| February 19, 2025 | NAI | Foods & Cosmetics · Food Composition, Standards, Labeling and Econ | 1253920 |
| September 21, 2021 | NAI | Foods & Cosmetics · Food Composition, Standards, Labeling and Econ | 1157191 |
| August 20, 2019 | NAI | Human Drugs · Drug Quality Assurance | 1105193 |
| November 10, 2016 | NAI | Foods & Cosmetics · Foodborne Biological Hazards | 993338 |
| October 28, 2016 | VAI | Foods & Cosmetics · Food Composition, Standards, Labeling and Econ | 991787 |
| April 28, 2016 | NAI | Foods & Cosmetics · Food Composition, Standards, Labeling and Econ | 969921 |
| February 7, 2014 | NAI | Foods & Cosmetics · Food Composition, Standards, Labeling and Econ | 864388 |
| February 1, 2013 | NAI | Foods & Cosmetics, Human Drugs · Food Composition, Standards, Labeling and Econ | 816165 |
| February 17, 2012 | VAI | Foods & Cosmetics, Human Drugs · Drug Quality Assurance | 769964 |
| November 1, 2011 | NAI | Human Drugs · Drug Quality Assurance | 751963 |
| December 3, 2010 | VAI | Foods & Cosmetics, Human Drugs · Drug Quality Assurance | 702650 |
| September 10, 2010 | NAI | Human Drugs · Drug Quality Assurance | 680327 |
| July 17, 2009 | VAI | Foods & Cosmetics, Human Drugs · Food Composition, Standards, Labeling and Econ | 589586 |
FDA documents
Form 483s (1)
Warning Letters (1)
Related Companies (10)
Companies with similar regulatory profiles, compliance history, and operations.
Company Information
Name
Schwabe North America, Inc.
FEI Number
2128693
Address
825 Challenger Dr, Green Bay, Wisconsin 54311, United States
Country
United States
ID: ac030767-09e8-4377-99ee-7360176e40ed