FDA Inspection
Trident SRLTrident SRL – FDA Inspection, Sep 17, 2026
Record Details
This FDA Inspection record concerns Trident SRL, with an inspection on September 17, 2026, issued by the Office of Inspections and Investigations, covering medical devices & rad health.
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ID · d95fd912-19d7-4676-9485-a2ee78af9df0
Inspection Facts
- Inspection number
- 1336028
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
- Outcome
- Form 483 issued
FDA Citations
7- 21 CFR 820.45(a)Labeling and packaging not examined for accuracy
- ISO 13485:2016 Clause 4.1.5Inadequate monitoring and control over outsourced processes
- ISO 13485:2016 Clause 5.6.2Input to management review is incomplete
- ISO 13485:2016 Clause 7.1Records of risk management activities in product realization not maintained
- ISO 13485:2016 Clause 7.4.1Records of supplier (re)evaluation, selection, and monitoring not maintained
- ISO 13485:2016 Clause 8.2.4Internal audit follow-up activities lack verification
- ISO 13485:2016 Clause 8.5.2Corrective action not taken
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Other FDA inspections of Trident SRL
1| Date | Classification | Office | Project area |
|---|---|---|---|
| June 8, 2023 | NAI | Center for Devices and Radiological Health | Radiation Control and Health Safety Act |
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