UNKNOWN
⚠️ Moderate Risk
FEI: 3002831782 • UNKNOWN • SAUDI ARABIA
FEI Number
3002831782
Location
UNKNOWN
Country
SAUDI ARABIAAddress
UNKNOWN, , UNKNOWN, , Saudi Arabia
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
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).
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.
CSTIC LBLG
The labeling appears to fail to comply with cosmetic labeling requirements of Section 602(a), and/or (b), and/or (c), and as identified by 21 C.F.R. Part 701.
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).
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 ENGLISH
Required label or labeling appears to not be in English in violation of 21 C.F.R. 201.15(c)(1).
LABELING
The article appears in violation of FPLA because of its placement, form and/or contents statement.
INCONSPICU
Information required by the Act to be on the label or labeling does not appear to be conspicuous enough as to render it likely to be read and understood by the ordinary individual under customary conditions of purchase and use.
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.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 5/13/2015 | 53DY02PERFUMES (FRAGRANCE PREPARATIONS) | 471CSTIC LBLG | New Orleans District Office (NOL-DO) |
| 10/31/2007 | 66VAL99MISCELLANEOUS PATENT MEDICINES, ETC. | Seattle District Office (SEA-DO) | |
| 10/31/2007 | 21IET05DATES (PIT FRUIT PUREES) | Seattle District Office (SEA-DO) | |
| 10/31/2007 | 21IET05DATES (PIT FRUIT PUREES) | Seattle District Office (SEA-DO) | |
| 10/31/2007 | 21IGT05DATES (PIT FRUIT PUREES) | Seattle District Office (SEA-DO) | |
| 10/31/2007 | 66VAL99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | Seattle District Office (SEA-DO) |
| 10/31/2007 | 50NGY18HENNA | Seattle District Office (SEA-DO) | |
| 8/4/2004 | 53DY02PERFUMES (FRAGRANCE PREPARATIONS) | 471CSTIC LBLG | Southwest Import District Office (SWI-DO) |
| 8/4/2004 | 53FH02HAIR TINTS (HAIR COLORING PREPARATIONS) | 11UNSAFE COL | Southwest Import District Office (SWI-DO) |
| 7/29/2002 | 66VIL99MISCELLANEOUS PATENT MEDICINES, ETC. | Detroit District Office (DET-DO) |
Frequently Asked Questions
What is UNKNOWN's FDA import refusal history?
UNKNOWN (FEI: 3002831782) has 10 FDA import refusal record(s) in our database, spanning from 7/29/2002 to 5/13/2015.
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's FEI number is 3002831782.
What types of violations has UNKNOWN received?
UNKNOWN has been cited for 9 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 come from?
All FDA import refusal data for UNKNOWN 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.