FDA Inspection
Polyganics Holding BVPolyganics Holding BV – FDA Inspection, Sep 4, 2025
Record Details
This FDA Inspection record concerns Polyganics Holding BV, with an inspection on September 4, 2025, issued by the Office of Inspections and Investigations, covering medical devices & rad health.
- Company
- Polyganics Holding BV
- Inspection Date
- September 4, 2025
- Product Type
- Medical Devices & Rad Health
View Company Profile
ID · 6d414e5e-f8b0-4bc7-b4f9-08ce02244f6d
Inspection Facts
No Action Indicated (NAI)
No objectionable conditions or practices were found during the inspection.
- Inspection number
- 1281780
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Medical Devices
- Outcome
- Form 483 issued
FDA Citations
3- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.40Procedures not adequately established or maintained
- 21 CFR 820.75(a)Lack of or inadequate process validation
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