Company
United StatesSurgical Instrument Manufacturers, LLC, Fenton, MO – FDA Inspections
Inspection records and compliance data for Surgical Instrument Manufacturers, LLC in Fenton, Missouri. 6 FDA inspections on record, 1 Form 483, last inspected October 08, 2026.
Company Profile
This profile covers Surgical Instrument Manufacturers, LLC based in Fenton, Missouri, United States.
FDA Inspection History
- FDA inspections
- 6
- OAI
- 0
- VAI
- 5
- NAI
- 1
- Form 483s
- 1
- Warning letters
- 0
First inspected July 20, 2010. Last inspected October 8, 2026.
Most cited issue areas
- Lack of or inadequate process validation3 inspections
- Document change records, maintained.1 inspection
- Lack of or inadequate procedures1 inspection
FDA inspections (6)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| October 8, 2026 | VAI | · Compliance: Devices | 1340262 |
| February 22, 2024 | VAI | Medical Devices & Rad Health · Compliance: Devices | 1230704 |
| October 27, 2021 | NAI | Medical Devices & Rad Health · Compliance: Devices | 1158788 |
| May 11, 2017 | VAI | Medical Devices & Rad Health · Compliance: Devices | 1019539 |
| January 15, 2014 | VAI | Medical Devices & Rad Health · Compliance: Devices | 863893 |
| July 20, 2010 | VAI | Medical Devices & Rad Health · Compliance: Devices | 674762 |
FDA documents
Form 483s (1)
People (1)
Related Companies (10)
Companies with similar regulatory profiles, compliance history, and operations.
Company Information
Name
Surgical Instrument Manufacturers, LLC
FEI Number
1935627
Address
2076 Fenton Logistics Park, Fenton, Missouri 63026, United States
Country
United States
ID: 3a124509-bd32-4dd4-80ec-fe770e81a142