UNIREGEN spol s.r.o. – FDA Inspection, Apr 25, 2025

Record Details

This FDA Inspection record concerns UNIREGEN spol s.r.o., with an inspection on April 25, 2025, issued by the Office of Inspections and Investigations, covering foods & cosmetics.

Company: UNIREGEN spol s.r.o.
Inspection Date: April 25, 2025
Product Type: Foods & Cosmetics
Office: Office of Inspections and Investigations
Person: Richard G. Fochesato (Company Rep)

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ID · 9eab9b23-0049-47e0-8a25-2097f1cb3aa5

Inspection Facts

Official Action Indicated (OAI)

Significant objectionable conditions were found and regulatory or administrative action is recommended.

Inspection number: 1268019
FDA center: Foods & Cosmetics
Project area: Foodborne Biological Hazards
Outcome: Form 483 issued

FDA Citations

21 CFR 111.70(b)Specifications - components
21 CFR 117.80(a)(2)Appropriate quality control operations
21 CFR 108.35(c)(3)(ii)Process information availability
21 CFR 111.75(c)Specifications met - verify; finished batch

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FDA Inspection

UNIREGEN spol s.r.o.April 25, 2025