GAMMA-A, Ltd
⚠️ Moderate Risk
FEI: 3003327816 • Riga, Riga • LATVIA
FEI Number
3003327816
Location
Riga, Riga
Country
LATVIAAddress
Traleru Iela 30, , Riga, Riga, Latvia
Moderate Risk
FDA Import Risk Assessment
This firm has a moderate history of FDA import refusals. Some attention may be warranted.
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
MFR INSAN
The article is subject to refusal of admission pursuant to section 801(a)(1) in that the article appears to have been manufactured, processed, or packed under insanitary conditions.
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.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 3/1/2016 | 16AGP33SARDINES (BRISLING, SPRATS, PILCHARDS, ETC.) | 308MFR INSAN | New York District Office (NYK-DO) |
| 3/1/2016 | 16AGP33SARDINES (BRISLING, SPRATS, PILCHARDS, ETC.) | 308MFR INSAN | New York District Office (NYK-DO) |
| 3/1/2016 | 16AGP33SARDINES (BRISLING, SPRATS, PILCHARDS, ETC.) | 308MFR INSAN | New York District Office (NYK-DO) |
| 12/23/2010 | 16AEE12COD | 83NO PROCESS | Los Angeles District Office (LOS-DO) |
| 1/28/2005 | 16SEP33SARDINES (BRISLING, SPRATS, PILCHARDS, ETC.), COLD SMOKED, FISH | 2580MFRHACCP | Chicago District Office (CHI-DO) |
Frequently Asked Questions
What is GAMMA-A, Ltd's FDA import refusal history?
GAMMA-A, Ltd (FEI: 3003327816) has 5 FDA import refusal record(s) in our database, spanning from 1/28/2005 to 3/1/2016.
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, Ltd's FEI number is 3003327816.
What types of violations has GAMMA-A, Ltd received?
GAMMA-A, Ltd has been cited for 3 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, Ltd come from?
All FDA import refusal data for GAMMA-A, Ltd 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.