FDA Inspection
Intronix Technologies CorporationIntronix Technologies Corporation – FDA Inspection, Feb 7, 2018
Record Details
This FDA Inspection record concerns Intronix Technologies Corporation, with an inspection on February 7, 2018, issued by the Office of Inspections and Investigations, covering medical devices & rad health.
- Inspection Date
- February 7, 2018
- Product Type
- Medical Devices & Rad Health
- Person
- James W. Whitney (Issuing Officer)
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ID · 516c7460-29fd-44ed-aacc-ba37de363021
Inspection Facts
- Inspection number
- 1040694
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
- Outcome
- Form 483 issued
FDA Citations
3- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.184DHR content
- 21 CFR 820.75(b)(2)Documentation of validated process performance
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Other FDA inspections of Intronix Technologies Corporation
1| Date | Classification | Office | Project area |
|---|---|---|---|
| February 26, 2015 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
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