Company
United StatesGendron Inc., Bryan, OH – FDA Inspections
Inspection records and compliance data for Gendron Inc. in Bryan, Ohio. 3 FDA inspections on record, 1 Form 483, last inspected March 16, 2018.
Company Profile
This profile covers Gendron Inc. based in Bryan, Ohio, United States.
FDA Inspection History
- FDA inspections
- 3
- OAI
- 0
- VAI
- 3
- NAI
- 0
- Form 483s
- 1
- Warning letters
- 0
First inspected September 11, 2009. Last inspected March 16, 2018.
Most cited issue areas
- Document review, approval documentation1 inspection
- Evaluation, timeliness, identification1 inspection
- Lack of or inadequate complaint procedures1 inspection
FDA inspections (3)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| March 16, 2018 | VAI | Medical Devices & Rad Health · Compliance: Devices | 1044724 |
| July 2, 2014 | VAI | Medical Devices & Rad Health · Compliance: Devices | 885340 |
| September 11, 2009 | VAI | Medical Devices & Rad Health · Compliance: Devices | 612343 |
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
Gendron Inc.
FEI Number
1523528
Address
520 W Mulberry St Ste 100, Bryan, Ohio 43506, United States
Country
United States
ID: c6dbe980-a47f-4959-ac00-9e78ec140102