Smithkline Beecham
⚠️ High Risk
FEI: 1000174169 • Brentford, Middlesex • UNITED KINGDOM
FEI
FEI Number
1000174169
📍
Location
Brentford, Middlesex
🇬🇧
Country
UNITED KINGDOM🏢
Address
8 B House, Great West Road, Brentford, Middlesex, United Kingdom
High Risk
FDA Import Risk Assessment
57.8
LowModerateHighCritical
This firm has a significant history of FDA import refusals with notable violations.
Statistics
129
Total Refusals
4
Unique Violations
3/29/2005
Latest Refusal
10/1/2001
Earliest Refusal
Score Breakdown
Violation Severity
60.8×40%
Refusal Volume
78.3×30%
Recency
0.0×20%
Frequency
100.0×10%
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
11892×
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).
7531×
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).
116×
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).
3213×
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.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 3/29/2005 | 66VCP99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 3/29/2005 | 66VCA99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 3/29/2005 | 66VCA99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 3/29/2005 | 66VCP99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 9/19/2003 | 60SAR99ANTACID, N.E.C. | 75UNAPPROVED | Los Angeles District Office (LOS-DO) |
| 9/19/2003 | 60SAR99ANTACID, N.E.C. | 75UNAPPROVED | Los Angeles District Office (LOS-DO) |
| 9/17/2003 | 60SAR99ANTACID, N.E.C. | 75UNAPPROVED | Los Angeles District Office (LOS-DO) |
| 8/12/2003 | 60SAR99ANTACID, N.E.C. | 118NOT LISTED | Los Angeles District Office (LOS-DO) |
| 8/12/2003 | 60SAR99ANTACID, N.E.C. | 118NOT LISTED | Los Angeles District Office (LOS-DO) |
| 8/12/2003 | 29BCO02SOFT DRINK, CITRUS FRUIT FLAVORED, CARBONATED | Los Angeles District Office (LOS-DO) | |
| 8/12/2003 | 29BEO02SOFT DRINK, CITRUS FRUIT FLAVORED, CARBONATED | Los Angeles District Office (LOS-DO) | |
| 8/12/2003 | 29BCO02SOFT DRINK, CITRUS FRUIT FLAVORED, CARBONATED | Los Angeles District Office (LOS-DO) | |
| 6/23/2003 | 60LBR99ANALGESIC, N.E.C. | 118NOT LISTED | Los Angeles District Office (LOS-DO) |
| 6/23/2003 | 60SAR99ANTACID, N.E.C. | 118NOT LISTED | Los Angeles District Office (LOS-DO) |
| 6/11/2003 | 29BCO02SOFT DRINK, CITRUS FRUIT FLAVORED, CARBONATED | 11UNSAFE COL | Los Angeles District Office (LOS-DO) |
| 6/11/2003 | 29BEO02SOFT DRINK, CITRUS FRUIT FLAVORED, CARBONATED | 11UNSAFE COL | Los Angeles District Office (LOS-DO) |
| 6/11/2003 | 29BCO02SOFT DRINK, CITRUS FRUIT FLAVORED, CARBONATED | 11UNSAFE COL | Los Angeles District Office (LOS-DO) |
| 6/6/2003 | 60SAR99ANTACID, N.E.C. | 118NOT LISTED | Chicago District Office (CHI-DO) |
| 5/1/2003 | 64HDL99EXPECTORANT N.E.C. | 118NOT LISTED | Florida District Office (FLA-DO) |
| 5/1/2003 | 64HDL99EXPECTORANT N.E.C. | 118NOT LISTED | Florida District Office (FLA-DO) |
| 4/30/2003 | 64HDL99EXPECTORANT N.E.C. | 118NOT LISTED | Florida District Office (FLA-DO) |
| 4/30/2003 | 64HDL99EXPECTORANT N.E.C. | 118NOT LISTED | Florida District Office (FLA-DO) |
| 4/25/2003 | 64HDL99EXPECTORANT N.E.C. | 118NOT LISTED | Florida District Office (FLA-DO) |
| 4/9/2003 | 64HDL99EXPECTORANT N.E.C. | 118NOT LISTED | Florida District Office (FLA-DO) |
| 4/9/2003 | 64HDL99EXPECTORANT N.E.C. | 75UNAPPROVED | Florida District Office (FLA-DO) |
| 4/9/2003 | 64HDL99EXPECTORANT N.E.C. | 75UNAPPROVED | Florida District Office (FLA-DO) |
| 4/2/2003 | 64HDL99EXPECTORANT N.E.C. | 118NOT LISTED | Florida District Office (FLA-DO) |
| 4/2/2003 | 64HDL99EXPECTORANT N.E.C. | 118NOT LISTED | Florida District Office (FLA-DO) |
| 4/2/2003 | 64HDL99EXPECTORANT N.E.C. | 118NOT LISTED | Florida District Office (FLA-DO) |
| 4/2/2003 | 64HDL99EXPECTORANT N.E.C. | 118NOT LISTED | Florida District Office (FLA-DO) |
| 4/2/2003 | 64HDL99EXPECTORANT N.E.C. | 118NOT LISTED | Florida District Office (FLA-DO) |
| 4/2/2003 | 64HDL99EXPECTORANT N.E.C. | 118NOT LISTED | Florida District Office (FLA-DO) |
| 4/2/2003 | 64HDL99EXPECTORANT N.E.C. | 118NOT LISTED | Florida District Office (FLA-DO) |
| 3/12/2003 | 64HDL99EXPECTORANT N.E.C. | 75UNAPPROVED | Florida District Office (FLA-DO) |
| 3/12/2003 | 64HDL99EXPECTORANT N.E.C. | 75UNAPPROVED | Florida District Office (FLA-DO) |
| 3/12/2003 | 64HDL99EXPECTORANT N.E.C. | 75UNAPPROVED | Florida District Office (FLA-DO) |
| 3/12/2003 | 64HDL99EXPECTORANT N.E.C. | 75UNAPPROVED | Florida District Office (FLA-DO) |
| 3/6/2003 | 64HDL99EXPECTORANT N.E.C. | 118NOT LISTED | Florida District Office (FLA-DO) |
| 3/6/2003 | 64HDL99EXPECTORANT N.E.C. | 118NOT LISTED | Florida District Office (FLA-DO) |
| 3/6/2003 | 64HDL99EXPECTORANT N.E.C. | 118NOT LISTED | Florida District Office (FLA-DO) |
| 3/6/2003 | 64HDL99EXPECTORANT N.E.C. | 118NOT LISTED | Florida District Office (FLA-DO) |
| 3/6/2003 | 64HDL99EXPECTORANT N.E.C. | 75UNAPPROVED | Florida District Office (FLA-DO) |
| 3/6/2003 | 64HDL99EXPECTORANT N.E.C. | 75UNAPPROVED | Florida District Office (FLA-DO) |
| 3/6/2003 | 64HDL99EXPECTORANT N.E.C. | 75UNAPPROVED | Florida District Office (FLA-DO) |
| 3/6/2003 | 64HDL99EXPECTORANT N.E.C. | 75UNAPPROVED | Florida District Office (FLA-DO) |
| 2/18/2003 | 64HDL99EXPECTORANT N.E.C. | 118NOT LISTED | Florida District Office (FLA-DO) |
| 2/10/2003 | 64HDL99EXPECTORANT N.E.C. | 118NOT LISTED | Florida District Office (FLA-DO) |
| 1/17/2003 | 64HDL99EXPECTORANT N.E.C. | 118NOT LISTED | Florida District Office (FLA-DO) |
| 1/17/2003 | 64HDL99EXPECTORANT N.E.C. | 118NOT LISTED | Florida District Office (FLA-DO) |
| 1/15/2003 | 64HDL99EXPECTORANT N.E.C. | 118NOT LISTED | Florida District Office (FLA-DO) |
| 11/6/2002 | 64HDL99EXPECTORANT N.E.C. | 118NOT LISTED | Florida District Office (FLA-DO) |
| 11/6/2002 | 64HDL99EXPECTORANT N.E.C. | 118NOT LISTED | Florida District Office (FLA-DO) |
| 11/6/2002 | 64HDL99EXPECTORANT N.E.C. | 118NOT LISTED | Florida District Office (FLA-DO) |
| 11/6/2002 | 64HDL99EXPECTORANT N.E.C. | 118NOT LISTED | Florida District Office (FLA-DO) |
| 11/6/2002 | 64HDL99EXPECTORANT N.E.C. | 118NOT LISTED | Florida District Office (FLA-DO) |
| 11/6/2002 | 64HDL99EXPECTORANT N.E.C. | 75UNAPPROVED | Florida District Office (FLA-DO) |
| 11/6/2002 | 64HDL99EXPECTORANT N.E.C. | 75UNAPPROVED | Florida District Office (FLA-DO) |
| 11/6/2002 | 64HDL99EXPECTORANT N.E.C. | 75UNAPPROVED | Florida District Office (FLA-DO) |
| 11/6/2002 | 64HDL99EXPECTORANT N.E.C. | 75UNAPPROVED | Florida District Office (FLA-DO) |
| 11/6/2002 | 64HDL99EXPECTORANT N.E.C. | 75UNAPPROVED | Florida District Office (FLA-DO) |
| 11/6/2002 | 64HDL99EXPECTORANT N.E.C. | 75UNAPPROVED | Florida District Office (FLA-DO) |
| 11/6/2002 | 64HDL99EXPECTORANT N.E.C. | 75UNAPPROVED | Florida District Office (FLA-DO) |
| 11/6/2002 | 64HDL99EXPECTORANT N.E.C. | 75UNAPPROVED | Florida District Office (FLA-DO) |
| 11/6/2002 | 64HDL99EXPECTORANT N.E.C. | 75UNAPPROVED | Florida District Office (FLA-DO) |
| 10/2/2002 | 64HDL99EXPECTORANT N.E.C. | 118NOT LISTED | Florida District Office (FLA-DO) |
| 9/30/2002 | 64HDL99EXPECTORANT N.E.C. | 118NOT LISTED | Florida District Office (FLA-DO) |
| 9/30/2002 | 64HDL99EXPECTORANT N.E.C. | 118NOT LISTED | Florida District Office (FLA-DO) |
| 9/19/2002 | 64HDL99EXPECTORANT N.E.C. | 118NOT LISTED | Florida District Office (FLA-DO) |
| 9/19/2002 | 64HDL99EXPECTORANT N.E.C. | 118NOT LISTED | Florida District Office (FLA-DO) |
| 9/19/2002 | 64HDL99EXPECTORANT N.E.C. | 118NOT LISTED | Florida District Office (FLA-DO) |
| 9/19/2002 | 64HDL99EXPECTORANT N.E.C. | 118NOT LISTED | Florida District Office (FLA-DO) |
| 9/19/2002 | 64HDL99EXPECTORANT N.E.C. | 75UNAPPROVED | Florida District Office (FLA-DO) |
| 9/19/2002 | 64HDL99EXPECTORANT N.E.C. | 75UNAPPROVED | Florida District Office (FLA-DO) |
| 9/9/2002 | 64HDL99EXPECTORANT N.E.C. | 118NOT LISTED | Florida District Office (FLA-DO) |
| 8/19/2002 | 64HDL99EXPECTORANT N.E.C. | 118NOT LISTED | Florida District Office (FLA-DO) |
| 8/19/2002 | 64HDL99EXPECTORANT N.E.C. | 118NOT LISTED | Florida District Office (FLA-DO) |
| 8/19/2002 | 64HDL99EXPECTORANT N.E.C. | 118NOT LISTED | Florida District Office (FLA-DO) |
| 8/19/2002 | 53IY01DENTIFRICES (AEROSOL, LIQUID, TOOTHPASTES, TOOTHPOWDERS), WITHOUT FLUORIDE (ORAL HYGIENE PRODUCTS) | 75UNAPPROVED | Florida District Office (FLA-DO) |
| 8/19/2002 | 53IY01DENTIFRICES (AEROSOL, LIQUID, TOOTHPASTES, TOOTHPOWDERS), WITHOUT FLUORIDE (ORAL HYGIENE PRODUCTS) | 75UNAPPROVED | Florida District Office (FLA-DO) |
| 8/7/2002 | 64HDL99EXPECTORANT N.E.C. | 118NOT LISTED | Florida District Office (FLA-DO) |
| 8/7/2002 | 64HDL99EXPECTORANT N.E.C. | 118NOT LISTED | Florida District Office (FLA-DO) |
| 8/7/2002 | 64HDL99EXPECTORANT N.E.C. | 118NOT LISTED | Florida District Office (FLA-DO) |
| 8/5/2002 | 64HDL99EXPECTORANT N.E.C. | 118NOT LISTED | Florida District Office (FLA-DO) |
| 8/5/2002 | 64HDL99EXPECTORANT N.E.C. | 118NOT LISTED | Florida District Office (FLA-DO) |
| 8/5/2002 | 64HDL99EXPECTORANT N.E.C. | 118NOT LISTED | Florida District Office (FLA-DO) |
| 8/2/2002 | 64HDL99EXPECTORANT N.E.C. | 118NOT LISTED | Florida District Office (FLA-DO) |
| 8/2/2002 | 64HDL99EXPECTORANT N.E.C. | 118NOT LISTED | Florida District Office (FLA-DO) |
| 7/11/2002 | 64HDL99EXPECTORANT N.E.C. | 75UNAPPROVED | 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) |
| 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) |
| 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) |
| 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's FDA import refusal history?
Smithkline Beecham (FEI: 1000174169) has 129 FDA import refusal record(s) in our database, spanning from 10/1/2001 to 3/29/2005.
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's FEI number is 1000174169.
What types of violations has Smithkline Beecham received?
Smithkline Beecham 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 come from?
All FDA import refusal data for Smithkline Beecham 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.