GFC KULA
⚠️ Moderate Risk
FEI: 3014718534 • Gori, None of the above • GEORGIA
FEI Number
3014718534
Location
Gori, None of the above
Country
GEORGIAAddress
17 Shindis Road, , Gori, None of the above, Georgia
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
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.
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.
LACKS N/C
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(e)(2) of the FD&C Act in that the food is in package form and the label fails to bear an accurate statement of the quantity of the contents in terms of weight, measure, or numerical count in accordance with Section 403(e)(2) of the FD&C Act.
UNAPPROVED
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be a new drug within the meaning of Section 201(p) without an approved New Drug Application (NDA).
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).
LABELING
The article appears in violation of FPLA because of its placement, form and/or contents statement.
DIETARY
The article purports to be or is represented for special dietary uses and its label does not appear to bear the nutritional information required by regulation.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 3/7/2016 | 20SDT01APPLE, CORE FRUIT JUICES OR CONCENTRATES | Los Angeles District Office (LOS-DO) | |
| 3/7/2016 | 54YYY99VITAMIN, MINERAL, PROTEINS AND UNCONVENTIONAL DIETARY SPECIALITIES FOR HUMANS AND ANIMALS, N.E.C. | Los Angeles District Office (LOS-DO) | |
| 3/7/2016 | 37JCT12PLUM SAUCE | Los Angeles District Office (LOS-DO) | |
| 3/7/2016 | 21DDT99MIXED FRUIT, JUICES OR CONCENTRATES N.E.C., | Los Angeles District Office (LOS-DO) | |
| 3/7/2016 | 20SDT04QUINCE, CORE FRUIT JUICES OR CONCENTRATES | Los Angeles District Office (LOS-DO) | |
| 3/7/2016 | 22KDT01POMEGRANATE, JUICE, OTHER FRUIT JUICES OR CONCENTRATES | Los Angeles District Office (LOS-DO) | |
| 3/7/2016 | 37JCT12PLUM SAUCE | Los Angeles District Office (LOS-DO) |
Frequently Asked Questions
What is GFC KULA's FDA import refusal history?
GFC KULA (FEI: 3014718534) has 7 FDA import refusal record(s) in our database, spanning from 3/7/2016 to 3/7/2016.
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. GFC KULA's FEI number is 3014718534.
What types of violations has GFC KULA received?
GFC KULA has been cited for 7 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 GFC KULA come from?
All FDA import refusal data for GFC KULA 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.