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MAZARE ALNAKHEEL ESTABLISHMENT

⚠️ Moderate Risk

FEI: 3015122053 • Jeddah, None of the above • SAUDI ARABIA

FEI

FEI Number

3015122053

📍

Location

Jeddah, None of the above

🇸🇦
🏢

Address

Buridah, Al Bsar, Omar Bin Abdulziz Road, , Jeddah, None of the above, Saudi Arabia

Moderate Risk

FDA Import Risk Assessment

44.5
LowModerateHighCritical

This firm has a moderate history of FDA import refusals. Some attention may be warranted.

Statistics

16
Total Refusals
7
Unique Violations
9/24/2019
Latest Refusal
4/9/2019
Earliest Refusal

Score Breakdown

Violation Severity
52.1×40%
Refusal Volume
45.6×30%
Recency
0.0×20%
Frequency
100.0×10%
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

32914×

JUICE %

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 the food purports to be a beverage containing vegetable or fruit juice and does not bear a statement on the label in appropriate prominence on the information panel of the total percentage of such fruit or vegetable juice contained therein.

48214×

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.

6214×

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).

8314×

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.

32112×

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.

21811×

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.

2412×

PESTICIDE

The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to bear or contain a pesticide chemical residue, which causes the article to be adulterated within the meaning of section 402(a)(2)(B) of the FD&C Act. Bears or contains:

Refusal History

DateProductViolationsDivision
9/24/2019
21VGT05MANGO, JUICE, MILK, CREME, DRINK OR NECTAR, SUB/TROPICAL FRUIT
321LACKS N/C
329JUICE %
482NUTRIT LBL
62NEEDS FCE
83NO PROCESS
Division of Northern Border Imports (DNBI)
9/24/2019
21VGT05MANGO, JUICE, MILK, CREME, DRINK OR NECTAR, SUB/TROPICAL FRUIT
321LACKS N/C
329JUICE %
482NUTRIT LBL
62NEEDS FCE
83NO PROCESS
Division of Northern Border Imports (DNBI)
9/24/2019
21VGT05MANGO, JUICE, MILK, CREME, DRINK OR NECTAR, SUB/TROPICAL FRUIT
321LACKS N/C
329JUICE %
482NUTRIT LBL
62NEEDS FCE
83NO PROCESS
Division of Northern Border Imports (DNBI)
9/24/2019
21VDF99SUTROPICAL AND TROPICAL FRUIT, JUICE, MILK, CREME, DRINK OR NECTAR, N.E.C.
218LIST INGRE
329JUICE %
482NUTRIT LBL
62NEEDS FCE
83NO PROCESS
Division of Northern Border Imports (DNBI)
9/24/2019
21VCF12PASSION FRUIT, JUICE, MILK, CREME, DRINK OR NECTAR, SUB/TROPICAL FRUIT
218LIST INGRE
329JUICE %
482NUTRIT LBL
62NEEDS FCE
83NO PROCESS
Division of Northern Border Imports (DNBI)
9/24/2019
20KCF06ORANGE, CITRUS FRUIT JUICES OR CONCENTRATES
218LIST INGRE
321LACKS N/C
329JUICE %
482NUTRIT LBL
62NEEDS FCE
83NO PROCESS
Division of Northern Border Imports (DNBI)
9/24/2019
21VDF07PINEAPPLE, JUICE, MILK, CREME, DRINK OR NECTAR, SUB/TROPICAL FRUIT
218LIST INGRE
321LACKS N/C
329JUICE %
482NUTRIT LBL
62NEEDS FCE
83NO PROCESS
Division of Northern Border Imports (DNBI)
9/24/2019
21DCF99MIXED FRUIT, JUICES OR CONCENTRATES N.E.C.,
218LIST INGRE
321LACKS N/C
329JUICE %
482NUTRIT LBL
62NEEDS FCE
83NO PROCESS
Division of Northern Border Imports (DNBI)
9/24/2019
21DCF07SUBTROPICAL/TROPICAL, MIXED, JUICES OR CONCENTRATES
218LIST INGRE
321LACKS N/C
329JUICE %
482NUTRIT LBL
62NEEDS FCE
83NO PROCESS
Division of Northern Border Imports (DNBI)
9/24/2019
20KCF06ORANGE, CITRUS FRUIT JUICES OR CONCENTRATES
218LIST INGRE
321LACKS N/C
329JUICE %
482NUTRIT LBL
62NEEDS FCE
83NO PROCESS
Division of Northern Border Imports (DNBI)
9/24/2019
20KCF06ORANGE, CITRUS FRUIT JUICES OR CONCENTRATES
218LIST INGRE
321LACKS N/C
329JUICE %
482NUTRIT LBL
62NEEDS FCE
83NO PROCESS
Division of Northern Border Imports (DNBI)
9/24/2019
21VCF05MANGO, JUICE, MILK, CREME, DRINK OR NECTAR, SUB/TROPICAL FRUIT
218LIST INGRE
321LACKS N/C
329JUICE %
482NUTRIT LBL
62NEEDS FCE
83NO PROCESS
Division of Northern Border Imports (DNBI)
9/24/2019
20KDF06ORANGE, CITRUS FRUIT JUICES OR CONCENTRATES
218LIST INGRE
321LACKS N/C
329JUICE %
482NUTRIT LBL
62NEEDS FCE
83NO PROCESS
Division of Northern Border Imports (DNBI)
9/24/2019
20KGT06ORANGE, CITRUS FRUIT JUICES OR CONCENTRATES
218LIST INGRE
321LACKS N/C
329JUICE %
482NUTRIT LBL
62NEEDS FCE
83NO PROCESS
Division of Northern Border Imports (DNBI)
4/9/2019
21HYT05DATES, DRIED OR PASTE
241PESTICIDE
Division of Northern Border Imports (DNBI)
4/9/2019
21HYT05DATES, DRIED OR PASTE
241PESTICIDE
Division of Northern Border Imports (DNBI)

Frequently Asked Questions

What is MAZARE ALNAKHEEL ESTABLISHMENT's FDA import refusal history?

MAZARE ALNAKHEEL ESTABLISHMENT (FEI: 3015122053) has 16 FDA import refusal record(s) in our database, spanning from 4/9/2019 to 9/24/2019.

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. MAZARE ALNAKHEEL ESTABLISHMENT's FEI number is 3015122053.

What types of violations has MAZARE ALNAKHEEL ESTABLISHMENT received?

MAZARE ALNAKHEEL ESTABLISHMENT 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 MAZARE ALNAKHEEL ESTABLISHMENT come from?

All FDA import refusal data for MAZARE ALNAKHEEL ESTABLISHMENT 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.