Company
United StatesBio-Research Associates Inc., Mequon, WI – FDA Inspections
Inspection records and compliance data for Bio-Research Associates Inc. in Mequon, Wisconsin. 3 FDA inspections on record, 1 Form 483, last inspected March 21, 2018.
Company Profile
This profile covers Bio-Research Associates Inc. based in Mequon, Wisconsin, United States.
FDA Inspection History
- FDA inspections
- 3
- OAI
- 0
- VAI
- 2
- NAI
- 1
- Form 483s
- 1
- Warning letters
- 0
First inspected November 13, 2009. Last inspected March 21, 2018.
Most cited issue areas
- Design changes - Lack of or Inadequate Procedures1 inspection
- DHR - not or inadequately maintained1 inspection
- Lack of or inadequate procedures1 inspection
FDA inspections (3)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| March 21, 2018 | VAI | Medical Devices & Rad Health · Compliance: Devices | 1046081 |
| April 23, 2015 | NAI | Medical Devices & Rad Health · Compliance: Devices | 923842 |
| November 13, 2009 | VAI | Medical Devices & Rad Health · Compliance: Devices | 626246 |
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
Bio-Research Associates Inc.
FEI Number
2183552
Address
12308 Corporate Pkwy Ste 450, Mequon, Wisconsin 53092-3385, United States
Country
United States
ID: 7a629039-2bbb-4d8e-a6d2-b653877f00c5