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FDA Inspection
•ADRIA SRL•December 4, 2025

ADRIA SRL – FDA Inspection, Dec 4, 2025

Record Details

This FDA Inspection record concerns ADRIA SRL, with an inspection on December 4, 2025, issued by the Office of Inspections and Investigations, covering medical devices & rad health.

Company
ADRIA SRL
Inspection Date
December 4, 2025
Product Type
Medical Devices & Rad Health
Office
Office of Inspections and Investigations
Person
  • Nakesh N. Gomanie (Issuing Officer)
View Company Profile

ID · 948d12a4-dfce-4b34-82f1-10930671ecdd

Inspection Facts

Inspection number
1293884
FDA center
Medical Devices & Rad Health
Project area
Compliance: Medical Devices
Outcome
Form 483 issued

FDA Citations

5
  1. 21 CFR 803.50(a)(2)Individual Report of Malfunction
  2. 21 CFR 820.100(a)Lack of or inadequate procedures
  3. 21 CFR 820.181DMR - not or inadequately maintained
  4. 21 CFR 820.184Lack of or inadequate DHR procedures
  5. 21 CFR 820.198(a)Lack of or inadequate complaint procedures

Full citation text and observation details available on the Dashboard.

Other FDA inspections of ADRIA SRL

1
DateClassificationOfficeProject area
March 16, 2023VAICenter for Devices and Radiological HealthCompliance: Devices
Other documents for ADRIA SRL
  • FDA Inspection 1200410 - 2023-03-16

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