Company
United StatesHelmer Inc., Noblesville, IN – FDA Inspections
Inspection records and compliance data for Helmer Inc. in Noblesville, Indiana. 4 FDA inspections on record, 1 Form 483, last inspected June 09, 2025.
Company Profile
This profile covers Helmer Inc. based in Noblesville, Indiana, United States.
FDA Inspection History
- FDA inspections
- 4
- OAI
- 0
- VAI
- 1
- NAI
- 2
- Unclassified
- 1
- Form 483s
- 1
- Warning letters
- 0
First inspected July 21, 2011. Last inspected June 9, 2025.
Most cited issue areas
- Lack of or inadequate complaint procedures1 inspection
- Lack of or inadequate process validation1 inspection
- Product rework procedures, Lack of or inadequate procedures1 inspection
FDA inspections (4)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| June 9, 2025 | Not classified | Medical Devices & Rad Health | 1273537 |
| July 31, 2017 | NAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 1020923 |
| June 4, 2014 | VAI | Medical Devices & Rad Health · Compliance: Devices | 881562 |
| July 21, 2011 | NAI | Medical Devices & Rad Health · Compliance: Devices | 735937 |
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
Helmer Inc.
FEI Number
3004973569
Address
14400 Bergen Blvd, Noblesville, Indiana 46060, United States
Country
United States
ID: 7bd9fd06-55ce-4e4f-91d3-dff47dd789ec