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ARZYTA

⚠️ Moderate Risk

FEI: 1000431460 • Ancaster, Ontario • CANADA

FEI

FEI Number

1000431460

📍

Location

Ancaster, Ontario

🇨🇦

Country

CANADA
🏢

Address

58 Carluke Rd W, Ss 102, Ancaster, Ontario, Canada

Moderate Risk

FDA Import Risk Assessment

44.4
LowModerateHighCritical

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

Statistics

27
Total Refusals
6
Unique Violations
5/7/2008
Latest Refusal
8/28/2003
Earliest Refusal

Score Breakdown

Violation Severity
56.4×40%
Refusal Volume
53.6×30%
Recency
0.0×20%
Frequency
57.5×10%
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

1112×

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).

27411×

COLOR LBLG

The article appears to contain an artificial coloring and it fails to bear labeling stating that fact.

2565×

INCONSPICU

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(f) of the FD&C Act in that any word, statement, or other information required by or under the authority of the FD&C Act to appear on the label or labeling is not prominently placed thereon with such conspicuousness (as compared with other words, statements, designs, or devices, in the labeling) and in such terms as to render it likely to be read and understood by the ordinary individual under customary terms of purchase and use (for example, label contains information in two or more languages but fails to repeat all required information in both languages in accordance with 21 CFR 101.15(c)(2), or label fails to include all required information in English in accordance with 21 CFR 101.15(c)(1), except in the case of articles distributed solely in the Commonwealth of Puerto Rico or in a Territory where the predominant language is one other than English)).

4734×

LABELING

The article appears in violation of FPLA because of its placement, form and/or contents statement.

2182×

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.

642×

YELLOW #5

The food appears to bear or contain the color additive FD & C Yellow No. 5, which is not declared on the label per 21 CFR 74.705(a)(c) under section 721.

Refusal History

DateProductViolationsDivision
5/7/2008
03REN35PASTRY, FRUIT OR JELLY FILLED, WITHOUT CUSTARD OR CREAM FILLING
11UNSAFE COL
New York District Office (NYK-DO)
5/7/2008
03REN35PASTRY, FRUIT OR JELLY FILLED, WITHOUT CUSTARD OR CREAM FILLING
11UNSAFE COL
New York District Office (NYK-DO)
5/7/2008
03REN35PASTRY, FRUIT OR JELLY FILLED, WITHOUT CUSTARD OR CREAM FILLING
11UNSAFE COL
New York District Office (NYK-DO)
1/14/2008
03REN35PASTRY, FRUIT OR JELLY FILLED, WITHOUT CUSTARD OR CREAM FILLING
11UNSAFE COL
274COLOR LBLG
Detroit District Office (DET-DO)
12/19/2007
03REN25PASTRY (OTHER THAN FRUIT OR JELLY FILLED) WITHOUT CUSTARD OR CREAM FILLING
256INCONSPICU
Detroit District Office (DET-DO)
12/19/2007
03REN25PASTRY (OTHER THAN FRUIT OR JELLY FILLED) WITHOUT CUSTARD OR CREAM FILLING
256INCONSPICU
Detroit District Office (DET-DO)
12/19/2007
03REN25PASTRY (OTHER THAN FRUIT OR JELLY FILLED) WITHOUT CUSTARD OR CREAM FILLING
256INCONSPICU
Detroit District Office (DET-DO)
12/19/2007
03REN35PASTRY, FRUIT OR JELLY FILLED, WITHOUT CUSTARD OR CREAM FILLING
11UNSAFE COL
256INCONSPICU
274COLOR LBLG
Detroit District Office (DET-DO)
12/10/2007
03REN35PASTRY, FRUIT OR JELLY FILLED, WITHOUT CUSTARD OR CREAM FILLING
11UNSAFE COL
274COLOR LBLG
Detroit District Office (DET-DO)
12/3/2007
03REN35PASTRY, FRUIT OR JELLY FILLED, WITHOUT CUSTARD OR CREAM FILLING
11UNSAFE COL
274COLOR LBLG
Detroit District Office (DET-DO)
12/3/2007
03RHN35PASTRY, FRUIT OR JELLY FILLED, WITHOUT CUSTARD OR CREAM FILLING
11UNSAFE COL
274COLOR LBLG
Detroit District Office (DET-DO)
8/20/2007
03RHN35PASTRY, FRUIT OR JELLY FILLED, WITHOUT CUSTARD OR CREAM FILLING
11UNSAFE COL
274COLOR LBLG
Detroit District Office (DET-DO)
8/20/2007
03RHN35PASTRY, FRUIT OR JELLY FILLED, WITHOUT CUSTARD OR CREAM FILLING
11UNSAFE COL
218LIST INGRE
Detroit District Office (DET-DO)
7/11/2007
03RHN35PASTRY, FRUIT OR JELLY FILLED, WITHOUT CUSTARD OR CREAM FILLING
11UNSAFE COL
New York District Office (NYK-DO)
6/5/2007
03RHN35PASTRY, FRUIT OR JELLY FILLED, WITHOUT CUSTARD OR CREAM FILLING
11UNSAFE COL
218LIST INGRE
New York District Office (NYK-DO)
3/27/2007
03RHN05COFFEE CAKE WITHOUT CUSTARD OR CREAM FILLING
274COLOR LBLG
New York District Office (NYK-DO)
10/6/2006
03NHT01CAKE,CUSTARD OR CREAM FILLED
256INCONSPICU
Detroit District Office (DET-DO)
10/4/2006
03RHN05COFFEE CAKE WITHOUT CUSTARD OR CREAM FILLING
274COLOR LBLG
New York District Office (NYK-DO)
10/4/2006
03RHN05COFFEE CAKE WITHOUT CUSTARD OR CREAM FILLING
274COLOR LBLG
New York District Office (NYK-DO)
10/4/2006
03RHN05COFFEE CAKE WITHOUT CUSTARD OR CREAM FILLING
274COLOR LBLG
New York District Office (NYK-DO)
10/13/2004
03AGN05ENGLISH MUFFINS
473LABELING
New Orleans District Office (NOL-DO)
10/13/2004
03RGN35PASTRY, FRUIT OR JELLY FILLED, WITHOUT CUSTARD OR CREAM FILLING
473LABELING
New Orleans District Office (NOL-DO)
10/13/2004
03AGN05ENGLISH MUFFINS
473LABELING
New Orleans District Office (NOL-DO)
10/13/2004
03AGN01BAGEL BREAD/ROLLS
473LABELING
New Orleans District Office (NOL-DO)
10/13/2004
03RYT01CAKE WITHOUT CUSTARD OR CREAM FILLING
274COLOR LBLG
New Orleans District Office (NOL-DO)
8/28/2003
03RMN05COFFEE CAKE WITHOUT CUSTARD OR CREAM FILLING
64YELLOW #5
New York District Office (NYK-DO)
8/28/2003
03RMN05COFFEE CAKE WITHOUT CUSTARD OR CREAM FILLING
64YELLOW #5
New York District Office (NYK-DO)

Frequently Asked Questions

What is ARZYTA's FDA import refusal history?

ARZYTA (FEI: 1000431460) has 27 FDA import refusal record(s) in our database, spanning from 8/28/2003 to 5/7/2008.

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. ARZYTA's FEI number is 1000431460.

What types of violations has ARZYTA received?

ARZYTA has been cited for 6 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 ARZYTA come from?

All FDA import refusal data for ARZYTA 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.