FDA Inspection
Jatex, Inc.Jatex, Inc. – FDA Inspection, Feb 18, 2026
Record Details
This FDA Inspection record concerns Jatex, Inc., with an inspection on February 18, 2026, issued by the Detroit District Office, covering medical devices & rad health.
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ID · 9ff123f9-2917-4ed4-a479-48b3cf5fd5ed
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1303422
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Medical Devices
- Outcome
- Form 483 issued
FDA Citations
4- ISO 13485:2016 Clause 7.5.1Production and service provision not adequate
- ISO 13485:2016 Clause 4.1.2Risk-based approach not applied to QMS processes
- ISO 13485:2016 Clause 8.3.1Procedure for nonconforming product not documented
- ISO 13485:2016 Clause 7.1Product realization risk management processes not documented
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Other FDA inspections of Jatex, Inc.
1| Date | Classification | Office | Project area |
|---|---|---|---|
| June 15, 2023 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
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