UNKNOWN MANUFACTURER
⚠️ Moderate Risk
FEI: 3002679898 • UNKNOWN • 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
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.
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.
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).
COLOR LBLG
The article appears to contain an artificial coloring and it fails to bear labeling stating that fact.
LACKS FIRM
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)(1) of the FD&C Act in that the food is in package form and the label fails to bear the name and place of business of the manufacturer, packer, or distributor.
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.
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.
POISONOUS
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to bear or contain a poisonous or deleterious substance which may render the article injurious to health. Contains:
FOREIGN OB
The article appears to consist in whole or in part of a filthy, putrid, or decomposed substance, or is otherwise unfit for food in that it appears to contain foreign objects.
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).
LACKS FIRM
The article is in package form and appears to not bear a label containing the name and place of business of the manufacturer, packer, or distributor.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 6/17/2024 | 26AGY06PEANUT OIL, CRUDE | 482NUTRIT LBL | Division of Northern Border Imports (DNBI) |
| 6/17/2024 | 54JBY11BETEL NUT (HERBAL AND BOTANICAL TEAS II, CONTINUED) | 251POISONOUS | Division of Northern Border Imports (DNBI) |
| 6/17/2024 | 54JBY11BETEL NUT (HERBAL AND BOTANICAL TEAS II, CONTINUED) | 251POISONOUS | Division of Northern Border Imports (DNBI) |
| 1/16/2024 | 29BCI99CARBONATED SOFT DRINK, N.E.C. | Division of Northeast Imports (DNEI) | |
| 1/16/2024 | 29BCI99CARBONATED SOFT DRINK, N.E.C. | Division of Northeast Imports (DNEI) | |
| 1/16/2024 | 29BCI99CARBONATED SOFT DRINK, N.E.C. | Division of Northeast Imports (DNEI) | |
| 10/29/2007 | 28AHT54PEPPER,BLACK, WHOLE (SPICE) | New York District Office (NYK-DO) | |
| 8/19/2004 | 16JGT05SHRIMP & PRAWNS | New York District Office (NYK-DO) | |
| 2/25/2004 | 65PAY02SILDENAFIL CITRATE (REGULATOR) | Seattle District Office (SEA-DO) |
Frequently Asked Questions
What is UNKNOWN MANUFACTURER's FDA import refusal history?
UNKNOWN MANUFACTURER (FEI: 3002679898) has 9 FDA import refusal record(s) in our database, spanning from 2/25/2004 to 6/17/2024.
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. UNKNOWN MANUFACTURER's FEI number is 3002679898.
What types of violations has UNKNOWN MANUFACTURER received?
UNKNOWN MANUFACTURER has been cited for 11 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 UNKNOWN MANUFACTURER come from?
All FDA import refusal data for UNKNOWN MANUFACTURER 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.