STERIL VERONA SRL – FDA Inspection, Mar 27, 2026

Record Details

This FDA Inspection record concerns STERIL VERONA SRL, with an inspection on March 27, 2026, issued by the Office of Inspections and Investigations, covering medical devices & rad health.

Company: STERIL VERONA SRL
Inspection Date: March 27, 2026
Product Type: Medical Devices & Rad Health
Office: Office of Inspections and Investigations
Person: Stephen D. Eich (Company Rep)

View Company Profile

ID · b46c2ddc-8b51-4e06-ac66-1e8109da58b6

Inspection Facts

Inspection number: 1309520
FDA center: Medical Devices & Rad Health
Project area: Compliance: Medical Devices
Outcome: Form 483 issued

FDA Citations

ISO 13485:2016 Clause 7.1Records of risk management activities in product realization not maintained
ISO 13485:2016 Clause 8.2.5Suitable methods for monitoring and measuring QMS processes not applied

Full citation text and observation details available on the Dashboard.

Discuss this record with AI

KeyPedia

ChatGPT

Claude

Perplexity

Grok

Copilot

Document or profile

One record shows the event. A profile shows the pattern.

Buy this document for the source file and details behind this single event.

Choose full profile access to connect related records, sites, people, citations, and enforcement history in one view.

Explore STERIL VERONA SRL

FDA Inspection

STERIL VERONA SRLMarch 27, 2026