Glaxosmithkline Caribbean Ltd
⚠️ Moderate Risk
FEI: 3003947605 • Kingston • JAMAICA
FEI Number
3003947605
Location
Kingston
Country
JAMAICAAddress
32 Beechwood Ave, , Kingston, , Jamaica
Moderate Risk
FDA Import Risk Assessment
This firm has a moderate history of FDA import refusals. Some attention may be warranted.
Statistics
Score Breakdown
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
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).
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.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 3/30/2017 | 05YHT99CEREAL PREPARATIONS NOT ELSEWHERE MENTIONED, N.E.C. | 482NUTRIT LBL | Division of Southeast Imports (DSEI) |
| 3/30/2017 | 05YHT99CEREAL PREPARATIONS NOT ELSEWHERE MENTIONED, N.E.C. | 482NUTRIT LBL | Division of Southeast Imports (DSEI) |
| 7/25/2003 | 60SAY11MAGNESIA (ANTACID) | 118NOT LISTED | Florida District Office (FLA-DO) |
| 7/25/2003 | 64BAA99DIURETIC N.E.C. | 118NOT LISTED | Florida District Office (FLA-DO) |
Frequently Asked Questions
What is Glaxosmithkline Caribbean Ltd's FDA import refusal history?
Glaxosmithkline Caribbean Ltd (FEI: 3003947605) has 4 FDA import refusal record(s) in our database, spanning from 7/25/2003 to 3/30/2017.
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. Glaxosmithkline Caribbean Ltd's FEI number is 3003947605.
What types of violations has Glaxosmithkline Caribbean Ltd received?
Glaxosmithkline Caribbean Ltd has been cited for 2 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 Glaxosmithkline Caribbean Ltd come from?
All FDA import refusal data for Glaxosmithkline Caribbean 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.