Saudi Nakhl
⚠️ Moderate Risk
FEI: 3005981735 • Jeddah • SAUDI ARABIA
FEI Number
3005981735
Location
Jeddah
Country
SAUDI ARABIAAddress
Po Box 4447, , Jeddah, , 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
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.
COSM COLOR
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to contain a color additive which is unsafe within the meaning of Section 721(a) which renders it adulterated under Section 601(e).
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).
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).
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).
COSMETLBLG
It appears that the cosmetic consists of two or more ingredients and the label does not list the common or usual name of each ingredient.
DRUG COLOR
The article appears to be a color additive the intended use of which is for the purpose of coloring only, and its packaging and labeling do not conform to regulations issued under section 721.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 3/28/2013 | 53LD03FACE,BODY,AND HAND (EXCLUDING SHAVING PREPARATIONS) (SKIN CARE PREPARATIONS) | 471CSTIC LBLG | Minneapolis District Office (MIN-DO) |
| 3/28/2013 | 50BGE60COLOR FOR COSMETIC (NOT CERTIFIED) | 11UNSAFE COL | Minneapolis District Office (MIN-DO) |
| 4/6/2012 | 53ED07TONICS, DRESSINGS, AND OTHER HAIR GROOMING AIDS (HAIR PREPARATIONS, NON-COLORING) | Seattle District Office (SEA-DO) | |
| 9/30/2011 | 53DD99OTHER FRAGRANCE PREPARATIONS, N.E.C. | Seattle District Office (SEA-DO) | |
| 9/30/2011 | 53EC99OTHER HAIR PREPARATIONS, NON-COLORING), N.E.C. | Seattle District Office (SEA-DO) | |
| 2/3/2011 | 53GC04LEG AND BODY PAINTS (MAKEUP PREPARATIONS, NOT FOR EYES) | 197COSM COLOR | Seattle District Office (SEA-DO) |
| 1/18/2011 | 53FH01HAIR DYES AND COLORS (ALL TYPES REQUIRE CAUTION STATEMENTS AND PATCH TESTS) (HAIR COLORING PREPARATI | 471CSTIC LBLG | Minneapolis District Office (MIN-DO) |
| 9/29/2010 | 53YC99OTHER COSMETIC AND COSMETIC PRODUCTS, N.E.C. | 75UNAPPROVED | Minneapolis District Office (MIN-DO) |
| 9/29/2010 | 53YC99OTHER COSMETIC AND COSMETIC PRODUCTS, N.E.C. | 75UNAPPROVED | Minneapolis District Office (MIN-DO) |
| 8/24/2010 | 53DD02PERFUMES (FRAGRANCE PREPARATIONS) | 471CSTIC LBLG | Minneapolis District Office (MIN-DO) |
| 8/24/2010 | 53JC99OTHER PERSONAL CLEANLINESS PRODUCTS (NOT ANTIPERSPIRANT), N.E.C. | 471CSTIC LBLG | Minneapolis District Office (MIN-DO) |
| 8/24/2010 | 53ED01HAIR CONDITIONERS (HAIR PREPARATIONS, NON-COLORING) | 197COSM COLOR | Minneapolis District Office (MIN-DO) |
| 8/24/2010 | 50BGE60COLOR FOR COSMETIC (NOT CERTIFIED) | 73DRUG COLOR | Minneapolis District Office (MIN-DO) |
| 8/26/2009 | 53LC06MOISTURIZING (SKIN CARE PREPARATIONS) | 197COSM COLOR | Minneapolis District Office (MIN-DO) |
| 8/26/2009 | 53LC06MOISTURIZING (SKIN CARE PREPARATIONS) | 197COSM COLOR | Minneapolis District Office (MIN-DO) |
| 4/10/2009 | 53FH05HAIR COLOR SPRAYS (HAIR COLORING PREPARATIONS) | 471CSTIC LBLG | Minneapolis District Office (MIN-DO) |
| 9/17/2008 | 53FH02HAIR TINTS (HAIR COLORING PREPARATIONS) | 471CSTIC LBLG | Minneapolis District Office (MIN-DO) |
| 9/17/2008 | 53FH02HAIR TINTS (HAIR COLORING PREPARATIONS) | 471CSTIC LBLG | Minneapolis District Office (MIN-DO) |
| 9/17/2008 | 53EC01HAIR CONDITIONERS (HAIR PREPARATIONS, NON-COLORING) | 471CSTIC LBLG | Minneapolis District Office (MIN-DO) |
| 9/17/2008 | 53YC99OTHER COSMETIC AND COSMETIC PRODUCTS, N.E.C. | Minneapolis District Office (MIN-DO) | |
| 9/17/2008 | 53EC01HAIR CONDITIONERS (HAIR PREPARATIONS, NON-COLORING) | Minneapolis District Office (MIN-DO) | |
| 9/17/2008 | 53EC01HAIR CONDITIONERS (HAIR PREPARATIONS, NON-COLORING) | Minneapolis District Office (MIN-DO) |
Frequently Asked Questions
What is Saudi Nakhl's FDA import refusal history?
Saudi Nakhl (FEI: 3005981735) has 22 FDA import refusal record(s) in our database, spanning from 9/17/2008 to 3/28/2013.
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. Saudi Nakhl's FEI number is 3005981735.
What types of violations has Saudi Nakhl received?
Saudi Nakhl 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 Saudi Nakhl come from?
All FDA import refusal data for Saudi Nakhl 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.