FDA Inspection
RX MedicalRX Medical – FDA Inspection, Mar 6, 2026
Record Details
This FDA Inspection record concerns RX Medical, with an inspection on March 6, 2026, issued by the Center for Devices and Radiological Health, covering devices.
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ID · 8690beea-2cec-4d50-adc2-eedd38185a7f
Inspection Facts
No Action Indicated (NAI)
No objectionable conditions or practices were found during the inspection.
- Inspection number
- 1307128
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
FDA Citations
6- ISO 13485:2016 Clause 8.2.4Evidence of conformity to the acceptance criteria not maintained
- ISO 13485:2016 Clause 7.5.6Process for production and service provision not validated
- ISO 13485:2016 Clause 4.1.2Risk-based approach not applied to QMS processes
- ISO 13485:2016 Clause 5.6.1Records of nonconforming product and actions taken not maintained
- ISO 13485:2016 Clause 8.3.1Records of nonconforming product and actions taken not maintained
- ISO 13485:2016 Clause 8.2.6Evidence of conformity to the acceptance criteria not maintained
Full citation text and observation details available on the Dashboard.
Other FDA inspections of RX Medical
3| Date | Classification | Office | Project area |
|---|---|---|---|
| April 23, 2019 | NAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
| June 9, 2014 | NAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
| March 27, 2012 | NAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
Other documents for RX Medical
- FDA Inspection 1090672 - 2019-04-23
- FDA Inspection 882481 - 2014-06-09
- FDA Inspection 774247 - 2012-03-27
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