Company
United StatesArch Medical Solutions - Elkhart, Elkhart, IN – FDA Inspections
Inspection records and compliance data for Arch Medical Solutions - Elkhart in Elkhart, Indiana. 2 FDA inspections on record, 1 Form 483, last inspected December 18, 2024.
Company Profile
This profile covers Arch Medical Solutions - Elkhart based in Elkhart, Indiana, United States.
FDA Inspection History
- FDA inspections
- 2
- OAI
- 0
- VAI
- 1
- NAI
- 1
- Form 483s
- 1
- Warning letters
- 0
First inspected August 6, 2021. Last inspected December 18, 2024.
Most cited issue areas
- Lack of or inadequate complaint procedures1 inspection
- Lack of or inadequate process validation1 inspection
- Nonconforming product, Lack of or inadequate procedures1 inspection
FDA inspections (2)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| December 18, 2024 | NAI | Medical Devices & Rad Health · Postmarket Assurance: Medical Devices | 1257334 |
| August 6, 2021 | VAI | Medical Devices & Rad Health · Compliance: Devices | 1148583 |
FDA documents
Form 483s (1)
People (1)
Related Companies (10)
Companies with similar regulatory profiles, compliance history, and operations.
Company Information
Name
Arch Medical Solutions - Elkhart
FEI Number
3009923627
Address
2921 Lavanture Pl, Elkhart, Indiana 46514, United States
Country
United States
ID: 83ada101-3f4d-4244-8dd3-a4eda3144b44