Company
United StatesLincotek Medical LLC., Vandalia, OH – FDA Inspections
Inspection records and compliance data for Lincotek Medical LLC. in Vandalia, Ohio. 4 FDA inspections on record, 1 Form 483, last inspected September 26, 2024.
Company Profile
This profile covers Lincotek Medical LLC. based in Vandalia, Ohio, United States.
FDA Inspection History
- FDA inspections
- 4
- OAI
- 0
- VAI
- 2
- NAI
- 2
- Form 483s
- 1
- Warning letters
- 0
First inspected April 28, 2015. Last inspected September 26, 2024.
Most cited issue areas
- Lack of or inadequate process validation1 inspection
FDA inspections (4)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| September 26, 2024 | NAI | Medical Devices & Rad Health · Postmarket Assurance: Medical Devices | 1250228 |
| November 19, 2021 | VAI | Medical Devices & Rad Health · Compliance: Devices | 1157207 |
| January 12, 2018 | NAI | Medical Devices & Rad Health · Compliance: Devices | 1040206 |
| April 28, 2015 | VAI | Medical Devices & Rad Health · Compliance: Devices | 929478 |
FDA documents
No Form 483s, Warning Letters or EIRs on record.
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Company Information
Name
Lincotek Medical LLC.
FEI Number
3010039400
Address
811 Northwoods Blvd, Vandalia, Ohio 45377, United States
Country
United States
ID: 5a3cecff-92ef-44e0-ab46-8c4d150b0d95