TOOTH FAIRY GMBH
⚠️ Moderate Risk
FEI: 3014662359 • Buchs Sg, St. Gallen • SWITZERLAND
FEI Number
3014662359
Location
Buchs Sg, St. Gallen
Country
SWITZERLANDAddress
Aeulistrasse 1, , Buchs Sg, St. Gallen, 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
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).
FRNMFGREG
The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded as defined in section 502(o) of the FD&C Act. It appears that it was manufactured, prepared, propagated, compounded, or processed in an establishment not duly registered under section 510 of the Act.
NO 510(K)
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it is a post 1976 device for which a Section 510(k)application does not appear to have been determined substantially equivalent or otherwise filed.
COSMETLBLG
It appears that the cosmetic consists of two or more ingredients and the label does not list the common or usual name of each ingredient.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 1/3/2020 | 53ID01DENTIFRICES (AEROSOL, LIQUID, TOOTHPASTES, TOOTHPOWDERS), WITHOUT FLUORIDE (ORAL HYGIENE PRODUCTS) | 475COSMETLBLG | Division of Southeast Imports (DSEI) |
| 1/3/2020 | 76EAZLIGHT, OPERATING, DENTAL | Division of Southeast Imports (DSEI) | |
| 12/31/2019 | 76EAZLIGHT, OPERATING, DENTAL | Division of Southeast Imports (DSEI) | |
| 12/31/2019 | 76EAZLIGHT, OPERATING, DENTAL | Division of Southeast Imports (DSEI) | |
| 12/31/2019 | 76EAZLIGHT, OPERATING, DENTAL | Division of Southeast Imports (DSEI) |
Frequently Asked Questions
What is TOOTH FAIRY GMBH's FDA import refusal history?
TOOTH FAIRY GMBH (FEI: 3014662359) has 5 FDA import refusal record(s) in our database, spanning from 12/31/2019 to 1/3/2020.
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. TOOTH FAIRY GMBH's FEI number is 3014662359.
What types of violations has TOOTH FAIRY GMBH received?
TOOTH FAIRY GMBH 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 TOOTH FAIRY GMBH come from?
All FDA import refusal data for TOOTH FAIRY GMBH 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.