Gamma-A SIA
⚠️ High Risk
FEI: 3005985506 • Riga • LATVIA
High Risk
FDA Import Risk Assessment
This firm has a significant history of FDA import refusals with notable violations.
Statistics
Score Breakdown
How is this score calculated?
Proprietary Algorithm
- 40% Violation Severity — AI-assessed (1-10)
- 30% Refusal Volume — Logarithmic scale
- 20% Recency — Decays over 5 years
- 10% Frequency — Refusals per year
© ImportRefusal.com Original Analysis
Violation Summary
MFRHACCP
The article is subject to refusal of admission pursuant to Section 801(a)(3) of the Act in that it appears to have been prepared, packed or held under insanitary conditions whereby it may have been rendered injurious to health in that it appears to have been processed in violation of 21 CFR 123.6(a) and 123.8(a).
NO PROCESS
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the manufacturer's failure to file a scheduled process demonstrates that the product is not being manufactured under the mandatory provisions of 21 CFR Part 108 and therefore appears to have been manufactured, processed, or packed, under insanitary conditions whereby it may have been rendered injurious to health.
NEEDS FCE
It appears the manufacturer is not registered as a low acid canned food or acidified food manufacturer pursuant to 21 CFR 108.25(c)(1) or 108.35(c)(1).
UNDER PRC
The article appears to have inadequate processing in having been prepared, packed, or held under insanitary conditions whereby it may have been rendered injurious to health.
LIST INGRE
The article is subject to refusal of admission pursuant to Section 801(a)(3) of the FD&C Act in that it appears to be misbranded within the meaning of Section 403(i)(2) of the FD&C Act in that it is fabricated from two or more ingredients and the label fails to bear the common or usual name of each such ingredient and/or the article purports to be a beverage containing vegetable or fruit juice, but does not bear a statement with appropriate prominence on the information panel of the total percentage of such fruit or vegetable juice contained in the food.
NUTRIT LBL
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be misbranded in that the label or labeling fails to bear the required nutrition information.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 1/7/2013 | 16AEE33SARDINES (BRISLING, SPRATS, PILCHARDS, ETC.) | New York District Office (NYK-DO) | |
| 1/7/2013 | 16AEE33SARDINES (BRISLING, SPRATS, PILCHARDS, ETC.) | New York District Office (NYK-DO) | |
| 1/7/2013 | 16AEE33SARDINES (BRISLING, SPRATS, PILCHARDS, ETC.) | New York District Office (NYK-DO) | |
| 1/7/2013 | 16AEE33SARDINES (BRISLING, SPRATS, PILCHARDS, ETC.) | New York District Office (NYK-DO) | |
| 1/7/2013 | 16ACE33SARDINES (BRISLING, SPRATS, PILCHARDS, ETC.) | New York District Office (NYK-DO) | |
| 5/29/2012 | 16AEE73MACKEREL (ALL EXCEPT SCOMBEROMORUS SP, EG SPANISH OR KING SEE '22') | New York District Office (NYK-DO) | |
| 5/29/2012 | 16AEE21HERRING | 181UNDER PRC | New York District Office (NYK-DO) |
| 6/2/2011 | 16AEE21HERRING | 2580MFRHACCP | New York District Office (NYK-DO) |
| 6/2/2011 | 16AEE21HERRING | 2580MFRHACCP | New York District Office (NYK-DO) |
| 6/2/2011 | 16AEE21HERRING | 2580MFRHACCP | New York District Office (NYK-DO) |
| 6/2/2011 | 16AEE21HERRING | 2580MFRHACCP | New York District Office (NYK-DO) |
| 6/2/2011 | 16AEE33SARDINES (BRISLING, SPRATS, PILCHARDS, ETC.) | 2580MFRHACCP | New York District Office (NYK-DO) |
| 6/2/2011 | 16AEE33SARDINES (BRISLING, SPRATS, PILCHARDS, ETC.) | 2580MFRHACCP | New York District Office (NYK-DO) |
| 6/2/2011 | 16AEE33SARDINES (BRISLING, SPRATS, PILCHARDS, ETC.) | 2580MFRHACCP | New York District Office (NYK-DO) |
| 6/2/2011 | 16AEE33SARDINES (BRISLING, SPRATS, PILCHARDS, ETC.) | 2580MFRHACCP | New York District Office (NYK-DO) |
| 6/2/2011 | 16AEE33SARDINES (BRISLING, SPRATS, PILCHARDS, ETC.) | 2580MFRHACCP | New York District Office (NYK-DO) |
| 6/2/2011 | 16AEE33SARDINES (BRISLING, SPRATS, PILCHARDS, ETC.) | 2580MFRHACCP | New York District Office (NYK-DO) |
| 6/2/2011 | 16AEE33SARDINES (BRISLING, SPRATS, PILCHARDS, ETC.) | 2580MFRHACCP | New York District Office (NYK-DO) |
| 6/2/2011 | 16AEE33SARDINES (BRISLING, SPRATS, PILCHARDS, ETC.) | 2580MFRHACCP | New York District Office (NYK-DO) |
| 6/2/2011 | 16AEE33SARDINES (BRISLING, SPRATS, PILCHARDS, ETC.) | 2580MFRHACCP | New York District Office (NYK-DO) |
| 3/24/2011 | 16AEE22MACKEREL (ONLY SCOMBEROMORUS SPP EG. SPANISH OR KING) | 2580MFRHACCP | New York District Office (NYK-DO) |
| 3/24/2011 | 16AEE22MACKEREL (ONLY SCOMBEROMORUS SPP EG. SPANISH OR KING) | 2580MFRHACCP | New York District Office (NYK-DO) |
| 3/24/2011 | 16YEE03FISH PASTE, FISHERY PRODUCTS, N.E.C. | 2580MFRHACCP | New York District Office (NYK-DO) |
| 3/24/2011 | 16AEE21HERRING | 2580MFRHACCP | New York District Office (NYK-DO) |
| 3/24/2011 | 16AEE21HERRING | 2580MFRHACCP | New York District Office (NYK-DO) |
| 3/24/2011 | 16AEE21HERRING | 2580MFRHACCP | New York District Office (NYK-DO) |
| 3/24/2011 | 16AEE33SARDINES (BRISLING, SPRATS, PILCHARDS, ETC.) | 2580MFRHACCP | New York District Office (NYK-DO) |
| 3/24/2011 | 16AEE33SARDINES (BRISLING, SPRATS, PILCHARDS, ETC.) | 2580MFRHACCP | New York District Office (NYK-DO) |
| 3/24/2011 | 16AEE33SARDINES (BRISLING, SPRATS, PILCHARDS, ETC.) | 2580MFRHACCP | New York District Office (NYK-DO) |
| 3/24/2011 | 16AEE33SARDINES (BRISLING, SPRATS, PILCHARDS, ETC.) | 2580MFRHACCP | New York District Office (NYK-DO) |
| 3/24/2011 | 16AEE33SARDINES (BRISLING, SPRATS, PILCHARDS, ETC.) | 2580MFRHACCP | New York District Office (NYK-DO) |
| 3/24/2011 | 16AEE33SARDINES (BRISLING, SPRATS, PILCHARDS, ETC.) | 2580MFRHACCP | New York District Office (NYK-DO) |
| 3/24/2011 | 16AEE33SARDINES (BRISLING, SPRATS, PILCHARDS, ETC.) | 2580MFRHACCP | New York District Office (NYK-DO) |
| 3/24/2011 | 16AEE33SARDINES (BRISLING, SPRATS, PILCHARDS, ETC.) | 2580MFRHACCP | New York District Office (NYK-DO) |
| 3/24/2011 | 16AEE33SARDINES (BRISLING, SPRATS, PILCHARDS, ETC.) | 2580MFRHACCP | New York District Office (NYK-DO) |
| 1/7/2011 | 16AET33SARDINES (BRISLING, SPRATS, PILCHARDS, ETC.) | 2580MFRHACCP | Detroit District Office (DET-DO) |
| 1/4/2007 | 16SEE33SARDINES (BRISLING, SPRATS, PILCHARDS, ETC.), COLD SMOKED, FISH | Detroit District Office (DET-DO) |
Frequently Asked Questions
What is Gamma-A SIA's FDA import refusal history?
Gamma-A SIA (FEI: 3005985506) has 37 FDA import refusal record(s) in our database, spanning from 1/4/2007 to 1/7/2013.
What is an FEI number?
FEI stands for Firm Establishment Identifier. It's a unique number assigned by the FDA to identify establishments that manufacture, process, pack, or hold food, drugs, medical devices, or other FDA-regulated products. Gamma-A SIA's FEI number is 3005985506.
What types of violations has Gamma-A SIA received?
Gamma-A SIA has been cited for 6 different violation type(s). Common FDA violations include adulteration (unsafe or unsanitary products), misbranding (incorrect or misleading labels), and regulatory non-compliance.
Where does this information about Gamma-A SIA come from?
All FDA import refusal data for Gamma-A SIA is sourced from the official FDA Data Dashboard (datadashboard.fda.gov), a public government database maintained by the U.S. Food and Drug Administration.
Data sourced from the FDA Data Dashboard, a public database maintained by the U.S. Food and Drug Administration.