FDA Inspection
SVTRONICS INCSVTRONICS INC – FDA Inspection, Feb 13, 2026
Record Details
This FDA Inspection record concerns SVTRONICS INC, with an inspection on February 13, 2026, issued by the Dallas District Office, covering medical devices & rad health.
- Office
- Dallas District Office
- Person
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ID · b8d1cf7e-8359-4afd-a74a-c77dc7b017ec
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1302724
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Medical Devices
- Outcome
- Form 483 issued
FDA Citations
3- ISO 13485:2016 Clause 7.4.3Records of purchased product verification not maintained
- ISO 13485:2016 Clause 7.5.6Procedures for validation of processes lack required elements
- ISO 13485:2016 Clause 8.1Methods for monitoring, measurement, analysis, and improvement not determined
Full citation text and observation details available on the Dashboard.
Other FDA inspections of SVTRONICS INC
3| Date | Classification | Office | Project area |
|---|---|---|---|
| November 9, 2022 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| March 14, 2019 | Not classified | Dallas District Office | |
| February 16, 2017 | Not classified | Dallas District Office |
Other documents for SVTRONICS INC
- FDA Inspection 1190677 - 2022-11-09
- FDA Inspection 1084220 - 2019-03-14
- FDA Inspection 1005577 - 2017-02-16
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