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PreGel S.p.A.

FDA import alert and refusal historyReggio Emilia, ItalyFEI 3004394020

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Example subjectPreGel S.p.A added to Import Alert 16-129 (red list)

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As of October 26, 2026, PreGel S.p.A. is not on any FDA import alert in SupplierRadar's records; FDA refused 1 of its shipment line on August 7, 2017, most often for fair packaging and labeling act (LABELING).

Data from FDA public records, last checked . Request a correction

Current status

Import alerts
Not listed
Last import refusal
Raw material for extracts and flavors, n.e.c. · LABELING
Last warning letter
None found
Last inspection
Classified VAI (Voluntary Action Indicated)

Every FDA record for PreGel S.p.A.

3 records, newest first. Each line links to the FDA page it came from.

2017

  1. Import refusal
    Refused, Raw material for extracts and flavors, n.e.c.LABELINGEntry AEK-3684575-5
    Source

2014

  1. Inspection
    Inspection classified VAI (Voluntary Action Indicated)Foodborne Biological Hazards
    Source

2011

  1. Inspection
    Inspection classified VAI (Voluntary Action Indicated)Foodborne Biological Hazards
    Source

Refusal charges, in plain English

  • LABELING1 refused line

    Fair Packaging and Labeling Act

    The package appeared not to meet the Fair Packaging and Labeling Act because of the placement, form, or contents of a required label statement.

Questions about PreGel S.p.A.

Is PreGel S.p.A. on an FDA import alert?
No listing for PreGel S.p.A. appears in the FDA import alerts SupplierRadar checked on October 26, 2026. Country-wide alerts may still apply to its products; see the Italy page.
Has FDA refused shipments from PreGel S.p.A.?
Yes. FDA refused 1 shipment line from PreGel S.p.A. on August 7, 2017. The most recent, on August 7, 2017, was raw material for extracts and flavors, n.e.c., charged as LABELING (fair packaging and labeling act).
Why did FDA refuse PreGel S.p.A.'s shipments?
The most frequent charge is LABELING (fair packaging and labeling act, 1 line).
When was PreGel S.p.A. last inspected by FDA?
FDA's most recent inspection of PreGel S.p.A. with a final classification is dated November 20, 2014 and was classified VAI (Voluntary Action Indicated).
What is PreGel S.p.A.'s FEI number?
PreGel S.p.A.'s FDA Establishment Identifier (FEI) is 3004394020.

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SupplierRadar is not affiliated with the U.S. Food and Drug Administration. Data comes from public FDA records and may contain errors. This is not legal advice; importers remain responsible for their supplier evaluations.