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UNIREGEN spol s.r.o.

FDA import alert and refusal historyNachod, Czech RepublicFEI 3013209770

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Example subjectUNIREGEN spol s.r.o added to Import Alert 16-129 (red list)

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As of October 26, 2026, UNIREGEN spol s.r.o. (Nachod, Czech Republic) is on the red list of FDA Import Alert 54-14 (Supplements from firms not meeting supplement GMP) for imuregen (liquid) products; imuregen glucan (capsules) products; imuregen (capsules) products, published by FDA on September 11, 2025, is also listed on Import Alert 99-37 (red list) and Import Alert 99-39 (red list), and has no FDA import refusals recorded since October 2016.

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

Current status

Import alerts
IA 54-14 · red listIA 99-37 · red listIA 99-39 · red list
Last import refusal
None since October 2016
Last warning letter
None found
Last inspection
Classified OAI (Official Action Indicated)

Every FDA record for UNIREGEN spol s.r.o.

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

2025

  1. Import alert listing
    Listed on Import Alert 54-14red listImuregen (liquid) products; Imuregen Glucan (Capsules) products; Imuregen (Capsules) products
    Source
  2. Import alert listing
    Listed on Import Alert 99-37red listImuregen (liquid) products
    Source
  3. Import alert listing
    Listed on Import Alert 99-39red listImuregen (liquid)
    Source
  4. Inspection
    Inspection classified OAI (Official Action Indicated)Food Composition, Standards, Labeling and Econ; Foodborne Biological Hazards
    Source

Questions about UNIREGEN spol s.r.o.

Is UNIREGEN spol s.r.o. on an FDA import alert?
Yes. As of October 26, 2026, UNIREGEN spol s.r.o. is on the red list of FDA Import Alert 54-14, “Supplements from firms not meeting supplement GMP”, for imuregen (liquid) products; imuregen glucan (capsules) products; imuregen (capsules) products; FDA published the listing on September 11, 2025.
Has FDA refused shipments from UNIREGEN spol s.r.o.?
No FDA import refusals for UNIREGEN spol s.r.o. appear in FDA's refusal data since October 2016, as of October 26, 2026.
When was UNIREGEN spol s.r.o. last inspected by FDA?
FDA's most recent inspection of UNIREGEN spol s.r.o. with a final classification is dated April 25, 2025 and was classified OAI (Official Action Indicated).
What is UNIREGEN spol s.r.o.'s FEI number?
UNIREGEN spol s.r.o.'s FDA Establishment Identifier (FEI) is 3013209770.
Can shipments from UNIREGEN spol s.r.o. still enter the U.S.?
Shipments of imuregen (liquid) products; imuregen glucan (capsules) products; imuregen (capsules) products from UNIREGEN spol s.r.o. can be detained without physical examination under Import Alert 54-14; 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 subjectUNIREGEN spol s.r.o 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.