SmithKline Beecham Limited
⚠️ High Risk
FEI: 1000166776 • Worthing, West Sussex • UNITED KINGDOM
FEI Number
1000166776
Location
Worthing, West Sussex
Country
UNITED KINGDOMAddress
Southdownview Way, , Worthing, West Sussex, 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
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).
LIST INGRE
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(i)(2) of the FD&C Act in that it is fabricated from two or more ingredients and the label fails to bear the common or usual name of each such ingredient and/or the article purports to be a beverage containing vegetable or fruit juice, but does not bear a statement with appropriate prominence on the information panel of the total percentage of such fruit or vegetable juice contained in the food.
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.
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 |
|---|---|---|---|
| 7/23/2024 | 56BCY03AMOXICILLIN TRIHYDRATE (PENICILLIN, SYNTHETICALLY PRODUCED) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 6/27/2024 | 56BCA03AMOXICILLIN TRIHYDRATE (PENICILLIN, SYNTHETICALLY PRODUCED) | 75UNAPPROVED | Division of Northeast Imports (DNEI) |
| 2/25/2021 | 56BDA03AMOXICILLIN TRIHYDRATE (PENICILLIN, SYNTHETICALLY PRODUCED) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 9/28/2017 | 56BCA03AMOXICILLIN TRIHYDRATE (PENICILLIN, SYNTHETICALLY PRODUCED) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 10/30/2009 | 56BCA03AMOXICILLIN TRIHYDRATE (PENICILLIN, SYNTHETICALLY PRODUCED) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 2/22/2007 | 61PAE99ANTI-DIABETIC N.E.C. | 75UNAPPROVED | Philadelphia District Office (PHI-DO) |
| 2/22/2007 | 61PIE99ANTI-DIABETIC N.E.C. | 75UNAPPROVED | Philadelphia District Office (PHI-DO) |
| 2/22/2007 | 61PIE99ANTI-DIABETIC N.E.C. | 75UNAPPROVED | Philadelphia District Office (PHI-DO) |
| 2/22/2007 | 61PCE99ANTI-DIABETIC N.E.C. | 75UNAPPROVED | Philadelphia District Office (PHI-DO) |
| 2/22/2007 | 61PCE99ANTI-DIABETIC N.E.C. | 75UNAPPROVED | Philadelphia District Office (PHI-DO) |
| 2/22/2007 | 61PCE99ANTI-DIABETIC N.E.C. | 75UNAPPROVED | Philadelphia District Office (PHI-DO) |
| 2/22/2007 | 61PCE99ANTI-DIABETIC N.E.C. | 75UNAPPROVED | Philadelphia District Office (PHI-DO) |
| 9/8/2003 | 30YYY99BEVERAGE BASE NOT MENTIONED ELSEWHERE, N.E.C. | Southwest Import District Office (SWI-DO) | |
| 9/8/2003 | 30YYY99BEVERAGE BASE NOT MENTIONED ELSEWHERE, N.E.C. | Southwest Import District Office (SWI-DO) |
Frequently Asked Questions
What is SmithKline Beecham Limited's FDA import refusal history?
SmithKline Beecham Limited (FEI: 1000166776) has 14 FDA import refusal record(s) in our database, spanning from 9/8/2003 to 7/23/2024.
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 Limited's FEI number is 1000166776.
What types of violations has SmithKline Beecham Limited received?
SmithKline Beecham Limited has been cited for 4 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 Limited come from?
All FDA import refusal data for SmithKline Beecham 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.