Gilgal Exports
⚠️ Moderate Risk
FEI: 3003661016 • Cochin • INDIA
FEI Number
3003661016
Location
Cochin
Country
INDIAAddress
1x/526 Chalissery House, Karingachira, , Cochin, , India
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
LABELING
The article appears in violation of FPLA because of its placement, form and/or contents statement.
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.
UNSAFE COL
The article appears to be, or to bear or contain a color additive which is unsafe within the meaning of Section 721(a).
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).
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.
FILTHY
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the article appears to consist in whole or in part of a filthy, putrid, or decomposed substance or be otherwise unfit for food.
HEALTH C
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 bears an unauthorized nutrient content/health claim.
USUAL NAME
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)(1) of the FD&C Act in that the label fails to bear the common or usual name of the food, if any there be.
NOT LISTED
It appears the drug or device is not included in a list required by Section 510(j), or a notice or other information respecting it was not provided as required by section 510(j) or 510(k).
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).
DIRECTIONS
The article is subject to refusal of admission pursuant to section 801(a)(3) in that it is a device whose label appears to not bear adequate directions for use.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 4/29/2004 | 21SGT14TAMARIND (SUBTROPICAL AND TROPICAL FRUIT) | Detroit District Office (DET-DO) | |
| 4/29/2004 | 29YGE99SOFT DRINKS AND WATERS NOT MENTIONED ELSEWHERE, N.E.C. | Detroit District Office (DET-DO) | |
| 4/29/2004 | 29YGE99SOFT DRINKS AND WATERS NOT MENTIONED ELSEWHERE, N.E.C. | Detroit District Office (DET-DO) | |
| 4/29/2004 | 23BFT99NUT, SHELLED, N.E.C. | Detroit District Office (DET-DO) | |
| 4/29/2004 | 61HBK99ANTI-BACTERIAL, N.E.C. | Detroit District Office (DET-DO) | |
| 4/29/2004 | 37KGI23CURRY PASTE | Detroit District Office (DET-DO) | |
| 4/29/2004 | 37KGI23CURRY PASTE | Detroit District Office (DET-DO) | |
| 4/29/2004 | 37KGI23CURRY PASTE | Detroit District Office (DET-DO) | |
| 4/29/2004 | 37KGI23CURRY PASTE | Detroit District Office (DET-DO) |
Frequently Asked Questions
What is Gilgal Exports's FDA import refusal history?
Gilgal Exports (FEI: 3003661016) has 9 FDA import refusal record(s) in our database, spanning from 4/29/2004 to 4/29/2004.
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. Gilgal Exports's FEI number is 3003661016.
What types of violations has Gilgal Exports received?
Gilgal Exports has been cited for 12 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 Gilgal Exports come from?
All FDA import refusal data for Gilgal Exports 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.