ImportRefusal LogoImportRefusal

Salada Foods Jamaica Limited

⚠️ Moderate Risk

FEI: 3002703353 • Kingston, JM-01 • JAMAICA

FEI

FEI Number

3002703353

📍

Location

Kingston, JM-01

🇯🇲

Country

JAMAICA
🏢

Address

20 Bell Road, , Kingston, JM-01, Jamaica

Moderate Risk

FDA Import Risk Assessment

27.5
LowModerateHighCritical

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

Statistics

1
Total Refusals
5
Unique Violations
10/12/2016
Latest Refusal
10/12/2016
Earliest Refusal

Score Breakdown

Violation Severity
58.0×40%
Refusal Volume
11.2×30%
Recency
0.0×20%
Frequency
10.0×10%
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

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).

161×

DIRECTIONS

The article is subject to refusal of admission pursuant to section 801(a)(3) in that it is a device whose label appears to not bear adequate directions for use.

3211×

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.

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.

751×

UNAPPROVED

The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be a new drug within the meaning of Section 201(p) without an approved New Drug Application (NDA).

Refusal History

DateProductViolationsDivision
10/12/2016
66YCY99EXHIBITS - OTHER DRUG RELATED ITEMS N.E.C.
118NOT LISTED
16DIRECTIONS
321LACKS N/C
3280FRNMFGREG
75UNAPPROVED
Division of Northeast Imports (DNEI)

Frequently Asked Questions

What is Salada Foods Jamaica Limited's FDA import refusal history?

Salada Foods Jamaica Limited (FEI: 3002703353) has 1 FDA import refusal record(s) in our database, spanning from 10/12/2016 to 10/12/2016.

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. Salada Foods Jamaica Limited's FEI number is 3002703353.

What types of violations has Salada Foods Jamaica Limited received?

Salada Foods Jamaica Limited 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 Salada Foods Jamaica Limited come from?

All FDA import refusal data for Salada Foods Jamaica 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.