Company
United StatesAmend Surgical, Inc., Alachua, FL – FDA Inspections
Inspection records and compliance data for Amend Surgical, Inc. in Alachua, Florida. 2 FDA inspections on record, 1 Form 483, last inspected March 06, 2025.
Company Profile
This profile covers Amend Surgical, Inc. based in Alachua, Florida, United States.
FDA Inspection History
- FDA inspections
- 2
- OAI
- 0
- VAI
- 1
- NAI
- 0
- Unclassified
- 1
- Form 483s
- 1
- Warning letters
- 0
First inspected November 9, 2018. Last inspected March 6, 2025.
Most cited issue areas
- Lack of or inadequate process validation1 inspection
- Purchasing controls, Lack of or inadequate procedures1 inspection
FDA inspections (2)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| March 6, 2025 | Not classified | Medical Devices & Rad Health | 1263898 |
| November 9, 2018 | VAI | Medical Devices & Rad Health · Compliance: Devices | 1071519 |
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
Amend Surgical, Inc.
FEI Number
3012161787
Address
14000 Nw 126th Ter, Alachua, Florida 32615, United States
Country
United States
ID: d3a944a3-d99a-4a24-966e-b487e438b1a1