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Smithkline Beecham Caribbean Ja Ltd

⚠️ Moderate Risk

FEI: 3003659363 • Kingston • JAMAICA

FEI

FEI Number

3003659363

📍

Location

Kingston

🇯🇲

Country

JAMAICA
🏢

Address

32 Beechwood Avenue, , Kingston, , Jamaica

Moderate Risk

FDA Import Risk Assessment

31.8
LowModerateHighCritical

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

Statistics

4
Total Refusals
1
Unique Violations
3/6/2003
Latest Refusal
6/17/2002
Earliest Refusal

Score Breakdown

Violation Severity
50.0×40%
Refusal Volume
25.9×30%
Recency
0.0×20%
Frequency
40.0×10%
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

1184×

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).

Refusal History

DateProductViolationsDivision
3/6/2003
64HDL99EXPECTORANT N.E.C.
118NOT LISTED
Florida District Office (FLA-DO)
6/17/2002
64HDL99EXPECTORANT N.E.C.
118NOT LISTED
Florida District Office (FLA-DO)
6/17/2002
64HDL99EXPECTORANT N.E.C.
118NOT LISTED
Florida District Office (FLA-DO)
6/17/2002
64HDL99EXPECTORANT N.E.C.
118NOT LISTED
Florida District Office (FLA-DO)

Frequently Asked Questions

What is Smithkline Beecham Caribbean Ja Ltd's FDA import refusal history?

Smithkline Beecham Caribbean Ja Ltd (FEI: 3003659363) has 4 FDA import refusal record(s) in our database, spanning from 6/17/2002 to 3/6/2003.

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. Smithkline Beecham Caribbean Ja Ltd's FEI number is 3003659363.

What types of violations has Smithkline Beecham Caribbean Ja Ltd received?

Smithkline Beecham Caribbean Ja Ltd has been cited for 1 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 Smithkline Beecham Caribbean Ja Ltd come from?

All FDA import refusal data for Smithkline Beecham Caribbean Ja 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.