FDA Inspection
Primo PassiPrimo Passi – FDA Inspection, Sep 23, 2026
Record Details
This FDA Inspection record concerns Primo Passi, with an inspection on September 23, 2026, issued by the Center for Devices and Radiological Health, covering medical devices & rad health.
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ID · 24fd5313-3346-4475-86d3-94b932ba5479
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1337268
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
- Outcome
- Form 483 issued
FDA Citations
3- ISO 13485:2016 Clause 4.1.4QMS processes not adequately managed
- ISO 13485:2016 Clause 4.1.3External party controls do not include written quality agreements
- ISO 13485:2016 Clause 4.1.5External party controls do not include written quality agreements
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