FDA Inspection
Lincotek Medical LLC.Lincotek Medical LLC. – FDA Inspection, Sep 26, 2024
Record Details
This FDA Inspection record concerns Lincotek Medical LLC., with an inspection on September 26, 2024, issued by the Cincinnati District Office, covering medical devices & rad health.
- Company
- Lincotek Medical LLC.
- Inspection Date
- September 26, 2024
- Product Type
- Medical Devices & Rad Health
View Company Profile
ID · 19a7ca38-25ef-457a-a689-84a288a4deba
Inspection Facts
No Action Indicated (NAI)
No objectionable conditions or practices were found during the inspection.
- Inspection number
- 1250228
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Medical Devices
- Outcome
- Form 483 issued
FDA Citations
1- 21 CFR 820.75(a)Lack of or inadequate process validation
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Lincotek Medical LLC.
3| Date | Classification | Office | Project area |
|---|---|---|---|
| November 19, 2021 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| January 12, 2018 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| April 28, 2015 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Lincotek Medical LLC.
- FDA Inspection 1157207 - 2021-11-19
- FDA Inspection 1040206 - 2018-01-12
- FDA Inspection 929478 - 2015-04-28
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