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Stanmark Processors Company Limited

⚠️ Moderate Risk

FEI: 3004299403 • Yallahs, Saint Thomas • JAMAICA

FEI

FEI Number

3004299403

📍

Location

Yallahs, Saint Thomas

🇯🇲

Country

JAMAICA
🏢

Address

Lots 213-216, Surry Ave. South Haven, Yallahs, Saint Thomas, Jamaica

Moderate Risk

FDA Import Risk Assessment

40.2
LowModerateHighCritical

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

Statistics

9
Total Refusals
10
Unique Violations
10/1/2021
Latest Refusal
11/3/2006
Earliest Refusal

Score Breakdown

Violation Severity
64.0×40%
Refusal Volume
37.0×30%
Recency
14.4×20%
Frequency
6.0×10%
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

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.

3212×

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.

37212×

PESTICIDE2

The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be adulterated because it contains a pesticide chemical, which is in violation of section 402(a)(2)(B). Contains:

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.

2492×

FILTHY

The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the article appears to consist in whole or in part of a filthy, putrid, or decomposed substance or be otherwise unfit for food.

5081×

NO 510(K)

The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it is a post 1976 device for which a Section 510(k)application does not appear to have been determined substantially equivalent or otherwise filed.

2601×

FALSE

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(a)(1 ) of the FD&C Act in that the labeling is false or misleading in any particular.

3201×

LACKS FIRM

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)(1) of the FD&C Act in that the food is in package form and the label fails to bear the name and place of business of the manufacturer, packer, or distributor.

621×

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).

32801×

FRNMFGREG

The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded as defined in section 502(o) of the FD&C Act. It appears that it was manufactured, prepared, propagated, compounded, or processed in an establishment not duly registered under section 510 of the Act.

Refusal History

DateProductViolationsDivision
10/1/2021
85HISCONDOM
3280FRNMFGREG
508NO 510(K)
Division of Northeast Imports (DNEI)
11/25/2020
21UGT14TAMARIND, JAM, JELLY, PRESERVES, MARMALADE, BUTTER OR CANDIED
249FILTHY
Division of Northeast Imports (DNEI)
11/4/2020
21UGT14TAMARIND, JAM, JELLY, PRESERVES, MARMALADE, BUTTER OR CANDIED
249FILTHY
Division of Northeast Imports (DNEI)
8/27/2014
21TET24PALM NUT (PALM FRUIT, SUGAR PALM), DRIED OR PASTE
3721PESTICIDE2
Division of Northeast Imports (DNEI)
5/31/2013
24TEE53CALLALOO (LEAF & STEM VEGETABLE)
3721PESTICIDE2
Division of Northeast Imports (DNEI)
11/30/2009
21SEE13ACKEES (SUBTROPICAL AND TROPICAL FRUIT)
321LACKS N/C
482NUTRIT LBL
New York District Office (NYK-DO)
11/30/2009
21SEE13ACKEES (SUBTROPICAL AND TROPICAL FRUIT)
260FALSE
320LACKS FIRM
321LACKS N/C
482NUTRIT LBL
New York District Office (NYK-DO)
11/3/2006
30AGO05BEVERAGE BASE, PIT FRUIT
83NO PROCESS
New York District Office (NYK-DO)
11/3/2006
20BCP14STRAWBERRIES, DRIED OR PASTE
62NEEDS FCE
83NO PROCESS
New York District Office (NYK-DO)

Frequently Asked Questions

What is Stanmark Processors Company Limited's FDA import refusal history?

Stanmark Processors Company Limited (FEI: 3004299403) has 9 FDA import refusal record(s) in our database, spanning from 11/3/2006 to 10/1/2021.

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. Stanmark Processors Company Limited's FEI number is 3004299403.

What types of violations has Stanmark Processors Company Limited received?

Stanmark Processors Company Limited has been cited for 10 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 Stanmark Processors Company Limited come from?

All FDA import refusal data for Stanmark Processors Company Limited 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.