GSK CONSUMER HEALTHCARE SCHWEIZ
⚠️ Moderate Risk
FEI: 3013891873 • Rotkreuz, Zug • SWITZERLAND
FEI Number
3013891873
Location
Rotkreuz, Zug
Country
SWITZERLANDAddress
Suurstoffi 14, , Rotkreuz, Zug, Switzerland
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).
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.
LACKS FIRM
The article is in package form and appears to not bear a label containing the name and place of business of the manufacturer, packer, or distributor.
LACKS N/C
The article is in package form and appears to not have a label containing an accurate statement of the quantity of the contents in terms of weight, measure or numerical count and no variations or exemptions have been prescribed by regs.
NO ENGLISH
Required label or labeling appears to not be in English in violation of 21 C.F.R. 201.15(c)(1).
DRUG NAME
The article appears to be a drug and fails to bear the proprietary or established name and/or name and quantity of each active ingredient.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 9/4/2018 | 62GCO18DICLOFENAC SODIUM (ANTI-INFLAMMATORY) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 8/30/2018 | 62GCO18DICLOFENAC SODIUM (ANTI-INFLAMMATORY) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 11/30/2017 | 60LBZ01ACETAMINOPHEN (ANALGESIC) | Division of Southeast Imports (DSEI) |
Frequently Asked Questions
What is GSK CONSUMER HEALTHCARE SCHWEIZ's FDA import refusal history?
GSK CONSUMER HEALTHCARE SCHWEIZ (FEI: 3013891873) has 3 FDA import refusal record(s) in our database, spanning from 11/30/2017 to 9/4/2018.
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. GSK CONSUMER HEALTHCARE SCHWEIZ's FEI number is 3013891873.
What types of violations has GSK CONSUMER HEALTHCARE SCHWEIZ received?
GSK CONSUMER HEALTHCARE SCHWEIZ 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 GSK CONSUMER HEALTHCARE SCHWEIZ come from?
All FDA import refusal data for GSK CONSUMER HEALTHCARE SCHWEIZ 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.