FDA Inspection
Cathtek LLCCathtek LLC – FDA Inspection, Feb 27, 2025
Record Details
This FDA Inspection record concerns Cathtek LLC, with an inspection on February 27, 2025, issued by the Center for Devices and Radiological Health, covering devices.
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ID · 052c0ccf-0e8e-44eb-9b22-d33b7e2ba7bc
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1262134
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
2- 21 CFR 820.100(b)Documentation
- 21 CFR 820.72(a)Equipment control activity documentation
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Cathtek LLC
1| Date | Classification | Office | Project area |
|---|---|---|---|
| August 8, 2019 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Cathtek LLC
- FDA Inspection 1106645 - 2019-08-08
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