Calugi, SRL – FDA Inspection, Oct 29, 2025

Record Details

This FDA Inspection record concerns Calugi, SRL, with an inspection on October 29, 2025, issued by the Office of Inspections and Investigations, covering foods & cosmetics.

Company: Calugi, SRL
Inspection Date: October 29, 2025
Product Type: Foods & Cosmetics
Office: Office of Inspections and Investigations
Person: Jane Chen (FDA Associated Person)

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ID · dd8324e3-ee85-498e-ac32-893f3a19c16e

Inspection Facts

Inspection number: 1289704
FDA center: Foods & Cosmetics
Project area: Foodborne Biological Hazards
Outcome: Form 483 issued

FDA Citations

21 CFR 108.35(c)(3)(i)Process adherence
21 CFR 113.100(a)(1)Still retorts
21 CFR 113.100(b)Review not signed/dated
21 CFR 113.40(a)(2)(iii)Adjusted to agree with TID
21 CFR 113.40(a)(8)Observable
21 CFR 113.60(a)Frequency: visual closure examinations, record
21 CFR 113.60(c)Coding - required elements
21 CFR 113.87(b)Visual indicators not used

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FDA Inspection

Calugi, SRLOctober 29, 2025