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GRACE KENNEDY JAMAICA LTD.

⚠️ High Risk

FEI: 3007477618 • Kingston, JM-01 • JAMAICA

FEI

FEI Number

3007477618

📍

Location

Kingston, JM-01

🇯🇲

Country

JAMAICA
🏢

Address

73 Harbour Street, , Kingston, JM-01, Jamaica

High Risk

FDA Import Risk Assessment

52.1
LowModerateHighCritical

This firm has a significant history of FDA import refusals with notable violations.

Statistics

4
Total Refusals
5
Unique Violations
8/22/2024
Latest Refusal
10/29/2003
Earliest Refusal

Score Breakdown

Violation Severity
74.3×40%
Refusal Volume
25.9×30%
Recency
72.3×20%
Frequency
1.9×10%
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

622×

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).

832×

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.

1181×

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).

3181×

VITAMN LBL

The food appears to be subject to section 411 and its advertising is false or misleading in a material respect or its labeling is in violation of section 411(b)(2).

33001×

ALLERGEN

the label fails to declare all major food allergens present in the product, as required by section 403(w)(1).

Refusal History

DateProductViolationsDivision
8/22/2024
03HGT02CHOCOLATE PLAIN COOKIES,BISCUITS AND WAFERS
318VITAMN LBL
3300ALLERGEN
Division of Southeast Imports (DSEI)
9/30/2006
66VAY99MISCELLANEOUS PATENT MEDICINES, ETC.
118NOT LISTED
Los Angeles District Office (LOS-DO)
12/8/2004
16AEI73MACKEREL (ALL EXCEPT SCOMBEROMORUS SP, EG SPANISH OR KING SEE '22')
62NEEDS FCE
83NO PROCESS
Florida District Office (FLA-DO)
10/29/2003
12AVT99CHEESE (STANDARDIZED),N.E.C.
62NEEDS FCE
83NO PROCESS
Florida District Office (FLA-DO)

Frequently Asked Questions

What is GRACE KENNEDY JAMAICA LTD.'s FDA import refusal history?

GRACE KENNEDY JAMAICA LTD. (FEI: 3007477618) has 4 FDA import refusal record(s) in our database, spanning from 10/29/2003 to 8/22/2024.

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. GRACE KENNEDY JAMAICA LTD.'s FEI number is 3007477618.

What types of violations has GRACE KENNEDY JAMAICA LTD. received?

GRACE KENNEDY JAMAICA LTD. has been cited for 5 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 GRACE KENNEDY JAMAICA LTD. come from?

All FDA import refusal data for GRACE KENNEDY JAMAICA LTD. 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.