SmithKline Beecham Ltd.
⚠️ High Risk
FEI: 3003711750 • Coleford, Gloucestershire • UNITED KINGDOM
FEI Number
3003711750
Location
Coleford, Gloucestershire
Country
UNITED KINGDOMAddress
The Royal Forest Factory, , Coleford, Gloucestershire, United Kingdom
High Risk
FDA Import Risk Assessment
This firm has a significant history of FDA import refusals with notable violations.
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
UNSAFE COL
The article appears to be, or to bear or contain a color additive which is unsafe within the meaning of Section 721(a).
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).
FLAVR LBLG
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to contain an artificial flavoring and it fails to bear labeling stating that fact.
COLOR LBLG
The article appears to contain an artificial coloring and it fails to bear labeling stating that fact.
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
| Date | Product | Violations | Division |
|---|---|---|---|
| 6/11/2024 | 29AGY99NONCARBONATED SOFT DRINK, N.E.C. | 274COLOR LBLG | Division of Northeast Imports (DNEI) |
| 8/22/2016 | 29BGT99CARBONATED SOFT DRINK, N.E.C. | 11UNSAFE COL | New York District Office (NYK-DO) |
| 2/10/2016 | 29AHT99NONCARBONATED SOFT DRINK, N.E.C. | 11UNSAFE COL | Division of Northeast Imports (DNEI) |
| 2/10/2016 | 29AHT99NONCARBONATED SOFT DRINK, N.E.C. | 11UNSAFE COL | Division of Northeast Imports (DNEI) |
| 5/5/2015 | 29BEE02SOFT DRINK, CITRUS FRUIT FLAVORED, CARBONATED | 11UNSAFE COL | Division of Northeast Imports (DNEI) |
| 10/20/2003 | 29BHT02SOFT DRINK, CITRUS FRUIT FLAVORED, CARBONATED | 11UNSAFE COL | Los Angeles District Office (LOS-DO) |
| 10/20/2003 | 29BHT02SOFT DRINK, CITRUS FRUIT FLAVORED, CARBONATED | 11UNSAFE COL | Los Angeles District Office (LOS-DO) |
| 10/20/2003 | 29BET02SOFT DRINK, CITRUS FRUIT FLAVORED, CARBONATED | 11UNSAFE COL | Los Angeles District Office (LOS-DO) |
| 10/10/2003 | 29BCT02SOFT DRINK, CITRUS FRUIT FLAVORED, CARBONATED | 258FLAVR LBLG | Los Angeles District Office (LOS-DO) |
| 5/23/2003 | 63RAJ04SODIUM FLUORIDE (DENTAL CARIES PROPHYLACTIC) | New York District Office (NYK-DO) |
Frequently Asked Questions
What is SmithKline Beecham Ltd.'s FDA import refusal history?
SmithKline Beecham Ltd. (FEI: 3003711750) has 10 FDA import refusal record(s) in our database, spanning from 5/23/2003 to 6/11/2024.
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. SmithKline Beecham Ltd.'s FEI number is 3003711750.
What types of violations has SmithKline Beecham Ltd. received?
SmithKline Beecham 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 SmithKline Beecham Ltd. come from?
All FDA import refusal data for SmithKline Beecham 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.