GlaxoSmithKline Consumer Healthcare
⚠️ Moderate Risk
FEI: 3004677760 • Weybridge, Surrey • UNITED KINGDOM
FEI Number
3004677760
Location
Weybridge, Surrey
Country
UNITED KINGDOMAddress
St. George'S Avenue, , Weybridge, Surrey, United Kingdom
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
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).
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).
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.
NEEDS FCE
It appears the manufacturer is not registered as a low acid canned food or acidified food manufacturer pursuant to 21 CFR 108.25(c)(1) or 108.35(c)(1).
NO PROCESS
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the manufacturer's failure to file a scheduled process demonstrates that the product is not being manufactured under the mandatory provisions of 21 CFR Part 108 and therefore appears to have been manufactured, processed, or packed, under insanitary conditions whereby it may have been rendered injurious to health.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 4/2/2012 | 60LAC99ANALGESIC, N.E.C. | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 2/21/2012 | 64UBA05CLAVULANATE POTASS./TICARCILLIN DISODIUM (INHIBITOR (DECARBOXYLASE)) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 1/10/2011 | 63RBQ04SODIUM FLUORIDE (DENTAL CARIES PROPHYLACTIC) | New Orleans District Office (NOL-DO) | |
| 9/21/2006 | 20DFT05CURRANTS, BLACK, JUICE OR CONCENTRATES | Los Angeles District Office (LOS-DO) |
Frequently Asked Questions
What is GlaxoSmithKline Consumer Healthcare's FDA import refusal history?
GlaxoSmithKline Consumer Healthcare (FEI: 3004677760) has 4 FDA import refusal record(s) in our database, spanning from 9/21/2006 to 4/2/2012.
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 Consumer Healthcare's FEI number is 3004677760.
What types of violations has GlaxoSmithKline Consumer Healthcare received?
GlaxoSmithKline Consumer Healthcare 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 GlaxoSmithKline Consumer Healthcare come from?
All FDA import refusal data for GlaxoSmithKline Consumer Healthcare 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.