Karagounis Bros. S.A.
FDA import alert and refusal historyVelestino, GreeceFEI 3009918652
As of October 26, 2026, Karagounis Bros. S.A. (Velestino, Greece) is on the red list of FDA Import Alert 16-120 (Seafood from processors not in compliance with HACCP) for all smoked fishery products, published by FDA on December 11, 2025, is also listed on Import Alert 16-74 (red list), and has 4 FDA import refusals recorded since October 2016.
Data from FDA public records, last checked . Request a correction
Current status
- Import alerts
- IA 16-120 · red listIA 16-74 · red list
- Last import refusal
- Herring, hot smoked, fish · MFRHACCP
- Last warning letter
- None found
- Last inspection
- Classified VAI (Voluntary Action Indicated)
Every FDA record for Karagounis Bros. S.A.
8 records, newest first. Each line links to the FDA page it came from.
2026
- Import refusalSource
Refused, 2 lines in one entry: Herring, hot smoked, fish; Mackerel, hot smoked, fish (only scomberomorus spp eg. spanish or king)MFRHACCPEntry 176-1045408-8Show 2 linesHide lines
2025
2022
- InspectionInspection classified VAI (Voluntary Action Indicated)Food Composition, Standards, Labeling and Econ; Foodborne Biological HazardsSource
2015
- Import alert listingListed on Import Alert 16-74red listCold Smoked Herring (Clupea Harengus)Source
- InspectionInspection classified VAI (Voluntary Action Indicated)Food Composition, Standards, Labeling and Econ; Foodborne Biological HazardsSource
Refusal charges, in plain English
- MFR INSAN2 refused lines
Insanitary manufacturing, processing or packing
The product appeared to have been manufactured, processed, or packed under insanitary conditions, which is a ground for refusal under section 801(a)(1) of the FD&C Act.
- MFRHACCP2 refused lines
Seafood HACCP requirements not met
The seafood appeared to have been processed without meeting the seafood HACCP requirements in 21 CFR 123.6(a) and 123.8(a), so it is treated as prepared under insanitary conditions.
Questions about Karagounis Bros. S.A.
- Is Karagounis Bros. S.A. on an FDA import alert?
- Yes. As of October 26, 2026, Karagounis Bros. S.A. is on the red list of FDA Import Alert 16-120, “Seafood from processors not in compliance with HACCP”, for all smoked fishery products; FDA published the listing on December 11, 2025.
- Has FDA refused shipments from Karagounis Bros. S.A.?
- Yes. FDA refused 4 shipment lines from Karagounis Bros. S.A. between November 12, 2025 and January 9, 2026. The most recent, on January 9, 2026, was herring, hot smoked, fish, charged as MFRHACCP (seafood haccp requirements not met).
- Why did FDA refuse Karagounis Bros. S.A.'s shipments?
- The most frequent charges are MFR INSAN (insanitary manufacturing, processing or packing, 2 lines) and MFRHACCP (seafood haccp requirements not met, 2 lines).
- When was Karagounis Bros. S.A. last inspected by FDA?
- FDA's most recent inspection of Karagounis Bros. S.A. with a final classification is dated May 24, 2022 and was classified VAI (Voluntary Action Indicated).
- What is Karagounis Bros. S.A.'s FEI number?
- Karagounis Bros. S.A.'s FDA Establishment Identifier (FEI) is 3009918652.
- Can shipments from Karagounis Bros. S.A. still enter the U.S.?
- Shipments of all smoked fishery products from Karagounis Bros. S.A. can be detained without physical examination under Import Alert 16-120; 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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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.