Glaxosmithkline
⚠️ Moderate Risk
FEI: 3003517780 • Buhl, Baden-Wurttemberg • GERMANY
FEI Number
3003517780
Location
Buhl, Baden-Wurttemberg
Country
GERMANYAddress
Busmatten 1, , Buhl, Baden-Wurttemberg, Germany
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
LABELING
The article appears in violation of FPLA because of its placement, form and/or contents statement.
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).
COSM COLOR
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to contain a color additive which is unsafe within the meaning of Section 721(a) which renders it adulterated under Section 601(e).
NO ENGLISH
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(f) of the FD&C Act in that any word, statement, or other information required by or under the authority of the FD&C Act to appear on the label or labeling is not prominently placed thereon with such conspicuousness (as compared with other words, statements, designs, or devices, in the labeling) and in such terms as to render it likely to be read and understood by the ordinary individual under customary terms of purchase and use (for example, label contains information in two or more languages but fails to repeat all required information in both languages in accordance with 21 CFR 101.15(c)(2), or label fails to include all required information in English in accordance with 21 CFR 101.15(c)(1), except in the case of articles distributed solely in the Commonwealth of Puerto Rico or in a Territory where the predominant language is one other than English)).
CSTIC LBLG
The labeling appears to fail to comply with cosmetic labeling requirements of Section 602(a), and/or (b), and/or (c), and as identified by 21 C.F.R. Part 701.
NO ENGLISH
Required label or labeling appears to not be in English in violation of 21 C.F.R. 201.15(c)(1).
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).
DIRECTIONS
The article is subject to refusal of admission pursuant to section 801(a)(3) in that it is a device whose label appears to not bear adequate directions for use.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 7/23/2021 | 63FCY06DIGOXIN (CARDIOTONIC) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 11/21/2012 | 63RBL04SODIUM FLUORIDE (DENTAL CARIES PROPHYLACTIC) | New York District Office (NYK-DO) | |
| 6/19/2012 | 63RBY06STANNOUS FLUORIDE (DENTAL CARIES PROPHYLACTIC) | New Orleans District Office (NOL-DO) | |
| 6/11/2012 | 53LC03FACE,BODY,AND HAND (EXCLUDING SHAVING PREPARATIONS) (SKIN CARE PREPARATIONS) | 471CSTIC LBLG | Los Angeles District Office (LOS-DO) |
| 12/5/2011 | 53IG01DENTIFRICES (AEROSOL, LIQUID, TOOTHPASTES, TOOTHPOWDERS), WITHOUT FLUORIDE (ORAL HYGIENE PRODUCTS) | 473LABELING | New Orleans District Office (NOL-DO) |
| 12/5/2011 | 53IG01DENTIFRICES (AEROSOL, LIQUID, TOOTHPASTES, TOOTHPOWDERS), WITHOUT FLUORIDE (ORAL HYGIENE PRODUCTS) | New Orleans District Office (NOL-DO) | |
| 11/16/2011 | 53ID01DENTIFRICES (AEROSOL, LIQUID, TOOTHPASTES, TOOTHPOWDERS), WITHOUT FLUORIDE (ORAL HYGIENE PRODUCTS) | 473LABELING | New Orleans District Office (NOL-DO) |
| 8/29/2011 | 76LCNSCRAPER, TONGUE | 118NOT LISTED | New Orleans District Office (NOL-DO) |
| 10/21/2005 | 54YIY99VITAMIN, MINERAL, PROTEINS AND UNCONVENTIONAL DIETARY SPECIALITIES FOR HUMANS AND ANIMALS, N.E.C. | 324NO ENGLISH | New Orleans District Office (NOL-DO) |
Frequently Asked Questions
What is Glaxosmithkline's FDA import refusal history?
Glaxosmithkline (FEI: 3003517780) has 9 FDA import refusal record(s) in our database, spanning from 10/21/2005 to 7/23/2021.
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's FEI number is 3003517780.
What types of violations has Glaxosmithkline received?
Glaxosmithkline has been cited for 8 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 come from?
All FDA import refusal data for Glaxosmithkline 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.