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Glaxo Smithklein

⚠️ Moderate Risk

FEI: 3007706279 • Mitcheldean, Gloucestershire • UNITED KINGDOM

FEI

FEI Number

3007706279

📍

Location

Mitcheldean, Gloucestershire

🇬🇧
🏢

Address

Building 9 3 Vantage Point Business Vill, , Mitcheldean, Gloucestershire, United Kingdom

Moderate Risk

FDA Import Risk Assessment

33.3
LowModerateHighCritical

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

Statistics

6
Total Refusals
6
Unique Violations
6/29/2010
Latest Refusal
12/8/2009
Earliest Refusal

Score Breakdown

Violation Severity
44.7×40%
Refusal Volume
31.3×30%
Recency
0.0×20%
Frequency
60.0×10%
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

4825×

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.

2744×

COLOR LBLG

The article appears to contain an artificial coloring and it fails to bear labeling stating that fact.

4733×

LABELING

The article appears in violation of FPLA because of its placement, form and/or contents statement.

112×

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).

3212×

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.

2181×

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.

Refusal History

DateProductViolationsDivision
6/29/2010
29BET99CARBONATED SOFT DRINK, N.E.C.
274COLOR LBLG
321LACKS N/C
482NUTRIT LBL
Los Angeles District Office (LOS-DO)
6/10/2010
29BET99CARBONATED SOFT DRINK, N.E.C.
11UNSAFE COL
218LIST INGRE
Los Angeles District Office (LOS-DO)
5/25/2010
29BET99CARBONATED SOFT DRINK, N.E.C.
274COLOR LBLG
321LACKS N/C
482NUTRIT LBL
Los Angeles District Office (LOS-DO)
12/8/2009
29BET99CARBONATED SOFT DRINK, N.E.C.
274COLOR LBLG
473LABELING
482NUTRIT LBL
Los Angeles District Office (LOS-DO)
12/8/2009
29BET99CARBONATED SOFT DRINK, N.E.C.
274COLOR LBLG
473LABELING
482NUTRIT LBL
Los Angeles District Office (LOS-DO)
12/8/2009
29BET99CARBONATED SOFT DRINK, N.E.C.
11UNSAFE COL
473LABELING
482NUTRIT LBL
Los Angeles District Office (LOS-DO)

Frequently Asked Questions

What is Glaxo Smithklein's FDA import refusal history?

Glaxo Smithklein (FEI: 3007706279) has 6 FDA import refusal record(s) in our database, spanning from 12/8/2009 to 6/29/2010.

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. Glaxo Smithklein's FEI number is 3007706279.

What types of violations has Glaxo Smithklein received?

Glaxo Smithklein has been cited for 6 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 Glaxo Smithklein come from?

All FDA import refusal data for Glaxo Smithklein 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.