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S.C. Amylon S.A.

FDA import alert and refusal historySibiu, RomaniaFEI 3007910962

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Example subjectS.C. Amylon S.A added to Import Alert 16-129 (red list)

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As of October 26, 2026, S.C. Amylon S.A. (Sibiu, Romania) is on the red list of FDA Import Alert 45-02 (Foods with illegal or undeclared colors) for lokum with fruit flavor (raha aroma fructe), published by FDA on March 8, 2016, and has 1 FDA import refusal recorded since October 2016.

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

Current status

Last import refusal
Jellied candy, soft (jelly beans, gum drops, etc.), with fruit (without chocolate) · UNSAFE COL
Last warning letter
None found
Last inspection
None on record

Every FDA record for S.C. Amylon S.A.

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

2018

  1. Import refusal
    Refused, Jellied candy, soft (jelly beans, gum drops, etc.), with fruit (without chocolate)UNSAFE COLEntry JBH-0139747-7
    Source

2016

  1. Import alert listing
    Listed on Import Alert 45-02red listLokum with Fruit Flavor (Raha Aroma Fructe)
    Source

Refusal charges, in plain English

  • UNSAFE COL1 refused line

    Color additive unsafe under section 721

    The product appeared to be, or to contain, a color additive that is unsafe within the meaning of section 721(a) of the FD&C Act, the section that governs which color additives may be used and how.

Questions about S.C. Amylon S.A.

Is S.C. Amylon S.A. on an FDA import alert?
Yes. As of October 26, 2026, S.C. Amylon S.A. is on the red list of FDA Import Alert 45-02, “Foods with illegal or undeclared colors”, for lokum with fruit flavor (raha aroma fructe); FDA published the listing on March 8, 2016.
Has FDA refused shipments from S.C. Amylon S.A.?
Yes. FDA refused 1 shipment line from S.C. Amylon S.A. on June 18, 2018. The most recent, on June 18, 2018, was jellied candy, soft (jelly beans, gum drops, etc.), with fruit (without chocolate), charged as UNSAFE COL (color additive unsafe under section 721).
Why did FDA refuse S.C. Amylon S.A.'s shipments?
The most frequent charge is UNSAFE COL (color additive unsafe under section 721, 1 line).
What is S.C. Amylon S.A.'s FEI number?
S.C. Amylon S.A.'s FDA Establishment Identifier (FEI) is 3007910962.
Can shipments from S.C. Amylon S.A. still enter the U.S.?
Shipments of lokum with fruit flavor (raha aroma fructe) from S.C. Amylon S.A. can be detained without physical examination under Import Alert 45-02; FDA releases them only if evidence shows they do not have the listed violation. Importers must consider this listing in their FSVP evaluation (21 CFR 1.505).

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Example subjectS.C. Amylon S.A added to Import Alert 16-129 (red list)

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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.