Company
United StatesAspen Surgical Products, Inc., Caledonia, MI – FDA Inspections
Inspection records and compliance data for Aspen Surgical Products, Inc. in Caledonia, Michigan. 4 FDA inspections on record, 1 Form 483, last inspected November 08, 2017.
Company Profile
This profile covers Aspen Surgical Products, Inc. based in Caledonia, Michigan, United States.
FDA Inspection History
- FDA inspections
- 4
- OAI
- 0
- VAI
- 2
- NAI
- 2
- Form 483s
- 1
- Warning letters
- 0
First inspected February 26, 2010. Last inspected November 8, 2017.
Most cited issue areas
- Design validation- Lack of or inadequate procedures1 inspection
- Documentation1 inspection
- Equipment design and installation1 inspection
FDA inspections (4)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| November 8, 2017 | NAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 1031151 |
| February 11, 2015 | NAI | Medical Devices & Rad Health · Compliance: Devices | 913454 |
| February 15, 2013 | VAI | Medical Devices & Rad Health · Compliance: Devices | 820190 |
| February 26, 2010 | VAI | Medical Devices & Rad Health · Compliance: Devices | 653652 |
FDA documents
Form 483s (1)
People (1)
Related Companies (10)
Companies with similar regulatory profiles, compliance history, and operations.
Company Information
Name
Aspen Surgical Products, Inc.
FEI Number
3002750084
Address
6945 Southbelt Dr Se, Caledonia, Michigan 49316, United States
Country
United States
ID: fff21709-664d-4d56-86a9-bd998aec52f9