Company
United StatesKatalyst Surgical, LLC, Chesterfield, MO – FDA Inspections
Inspection records and compliance data for Katalyst Surgical, LLC in Chesterfield, Missouri. 3 FDA inspections on record, 2 Form 483s, last inspected July 16, 2025.
Company Profile
This profile covers Katalyst Surgical, LLC based in Chesterfield, Missouri, United States.
FDA Inspection History
- FDA inspections
- 3
- OAI
- 0
- VAI
- 1
- NAI
- 1
- Unclassified
- 1
- Form 483s
- 2
- Warning letters
- 0
First inspected March 15, 2016. Last inspected July 16, 2025.
Most cited issue areas
- Nonconforming product, Lack of or inadequate procedures2 inspections
- Conducting an Investigation1 inspection
- Contamination control, Lack of or inadequate procedures1 inspection
FDA inspections (3)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| July 16, 2025 | Not classified | Medical Devices & Rad Health · Compliance: Medical Devices | 1275730 |
| August 7, 2017 | VAI | Medical Devices & Rad Health · Compliance: Devices | 1020942 |
| March 15, 2016 | NAI | Medical Devices & Rad Health · Radiation Control and Health Safety Act | 966433 |
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
Katalyst Surgical, LLC
FEI Number
3007589150
Address
754 Goddard Ave, Chesterfield, Missouri 63005, United States
Country
United States
ID: afe7fd4c-462e-4fe4-8035-625bc5864f2f