Company
United StatesCoreLink LLC, Fenton, MO – FDA Inspections
Inspection records and compliance data for CoreLink LLC in Fenton, Missouri. 5 FDA inspections on record, last inspected July 27, 2022.
Company Profile
This profile covers CoreLink LLC based in Fenton, Missouri, United States.
FDA Inspection History
- FDA inspections
- 5
- OAI
- 0
- VAI
- 3
- NAI
- 2
- Form 483s
- 0
- Warning letters
- 0
First inspected November 12, 2010. Last inspected July 27, 2022.
Most cited issue areas
- Design review - Lack of or inadequate procedures1 inspection
- Documentation1 inspection
- Quality Audits - defined intervals1 inspection
FDA inspections (5)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| July 27, 2022 | NAI | Biologics · Human Cellular, Tissue, and Gene Therapies | 1176784 |
| July 21, 2017 | NAI | Medical Devices & Rad Health · Compliance: Devices | 1019655 |
| July 9, 2015 | VAI | Biologics, Medical Devices & Rad Health · Compliance: Devices | 933648 |
| February 4, 2013 | VAI | Medical Devices & Rad Health · Compliance: Devices | 818928 |
| November 12, 2010 | VAI | Biologics, Medical Devices & Rad Health · Compliance: Devices | 698189 |
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
CoreLink LLC
FEI Number
3006494201
Address
2072 Fenton Logistics Park, Fenton, Missouri 63026, United States
Country
United States
ID: c85f28dc-c207-4608-861e-4382e9ab21f9