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Kerry (Canada)

⚠️ Moderate Risk

FEI: 3004641262 • Sainte-Claire, Quebec • CANADA

FEI

FEI Number

3004641262

📍

Location

Sainte-Claire, Quebec

🇨🇦

Country

CANADA
🏢

Address

187 Begin Blvd, , Sainte-Claire, Quebec, Canada

Moderate Risk

FDA Import Risk Assessment

27.0
LowModerateHighCritical

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

Statistics

5
Total Refusals
4
Unique Violations
2/10/2015
Latest Refusal
2/2/2009
Earliest Refusal

Score Breakdown

Violation Severity
43.8×40%
Refusal Volume
28.8×30%
Recency
0.0×20%
Frequency
8.3×10%
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

4734×

LABELING

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

4822×

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.

3241×

NO ENGLISH

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)).

831×

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.

Refusal History

DateProductViolationsDivision
2/10/2015
14YDF99FILLED OR IMITATION MILK OR MILK TYPE PRODUCTS NOT ELSEWHERE MENTIONED, N.E.C.
473LABELING
San Juan District Office (SJN-DO)
2/10/2015
14YDF99FILLED OR IMITATION MILK OR MILK TYPE PRODUCTS NOT ELSEWHERE MENTIONED, N.E.C.
473LABELING
San Juan District Office (SJN-DO)
2/10/2015
14YDF99FILLED OR IMITATION MILK OR MILK TYPE PRODUCTS NOT ELSEWHERE MENTIONED, N.E.C.
473LABELING
San Juan District Office (SJN-DO)
10/25/2012
40NHI01MILK BASE INFANT FORMULA PRODUCT (0-12 MONTHS), READY TO FEED
324NO ENGLISH
473LABELING
482NUTRIT LBL
83NO PROCESS
New York District Office (NYK-DO)
2/2/2009
41GGE01NUTRITIONALLY COMPLETE FORMULATIONS
482NUTRIT LBL
Detroit District Office (DET-DO)

Frequently Asked Questions

What is Kerry (Canada)'s FDA import refusal history?

Kerry (Canada) (FEI: 3004641262) has 5 FDA import refusal record(s) in our database, spanning from 2/2/2009 to 2/10/2015.

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. Kerry (Canada)'s FEI number is 3004641262.

What types of violations has Kerry (Canada) received?

Kerry (Canada) has been cited for 4 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 Kerry (Canada) come from?

All FDA import refusal data for Kerry (Canada) 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.