Company
United StatesBoehringer Ingelheim Fremont, Inc., Fremont, CA – FDA Inspections
Inspection records and compliance data for Boehringer Ingelheim Fremont, Inc. in Fremont, California. 8 FDA inspections on record, 3 Form 483s, last inspected May 16, 2024.
Company Profile
This profile covers Boehringer Ingelheim Fremont, Inc. based in Fremont, California, United States.
FDA Inspection History
- FDA inspections
- 8
- OAI
- 0
- VAI
- 4
- NAI
- 1
- Unclassified
- 3
- Form 483s
- 3
- Warning letters
- 0
First inspected February 25, 2010. Last inspected May 16, 2024.
Most cited issue areas
- Procedures not in writing, fully followed2 inspections
- Components withheld from use pending release1 inspection
- Equipment Design, Size and Location1 inspection
FDA inspections (8)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| May 16, 2024 | Not classified | Human Drugs | 1263388 |
| April 13, 2023 | Not classified | Human Drugs | 1205076 |
| November 4, 2022 | VAI | Human Drugs · Drug Quality Assurance | 1187410 |
| August 24, 2018 | VAI | Human Drugs, Medical Devices & Rad Health · Drug Quality Assurance | 1063730 |
| April 4, 2017 | Not classified | Human Drugs | 1005958 |
| May 28, 2014 | NAI | Human Drugs · Drug Quality Assurance | 882791 |
| August 7, 2012 | VAI | Human Drugs · Drug Quality Assurance | 793286 |
| February 25, 2010 | VAI | Human Drugs · Drug Quality Assurance | 653544 |
FDA documents
People (6)
Related Companies (10)
Companies with similar regulatory profiles, compliance history, and operations.
Company Information
Name
Boehringer Ingelheim Fremont, Inc.
FEI Number
3005925062
Address
6701 Kaiser Dr, Fremont, California 94555, United States
Country
United States
ID: 3d7d0ca7-27cd-4223-8ade-7193417c9861