ETOL GESUNDHEITSPFLEGE-UND PHARMAPRODUKTE GMBH
✅ Low Risk
FEI: 3003341442 • Oberkirch, Baden-Wurttemberg • GERMANY
FEI Number
3003341442
Location
Oberkirch, Baden-Wurttemberg
Country
GERMANYAddress
Konrad-Adenauer-Str. 3, , Oberkirch, Baden-Wurttemberg, Germany
Low Risk
FDA Import Risk Assessment
This firm has a minimal history of FDA import refusals with low-severity violations.
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 ENGLISH
Required label or labeling appears to not be in English in violation of 21 C.F.R. 201.15(c)(1).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 1/17/2018 | 63RBY06STANNOUS FLUORIDE (DENTAL CARIES PROPHYLACTIC) | Division of Southeast Imports (DSEI) | |
| 1/17/2018 | 63RBY06STANNOUS FLUORIDE (DENTAL CARIES PROPHYLACTIC) | Division of Southeast Imports (DSEI) |
Frequently Asked Questions
What is ETOL GESUNDHEITSPFLEGE-UND PHARMAPRODUKTE GMBH's FDA import refusal history?
ETOL GESUNDHEITSPFLEGE-UND PHARMAPRODUKTE GMBH (FEI: 3003341442) has 2 FDA import refusal record(s) in our database, spanning from 1/17/2018 to 1/17/2018.
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. ETOL GESUNDHEITSPFLEGE-UND PHARMAPRODUKTE GMBH's FEI number is 3003341442.
What types of violations has ETOL GESUNDHEITSPFLEGE-UND PHARMAPRODUKTE GMBH received?
ETOL GESUNDHEITSPFLEGE-UND PHARMAPRODUKTE GMBH has been cited for 3 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 ETOL GESUNDHEITSPFLEGE-UND PHARMAPRODUKTE GMBH come from?
All FDA import refusal data for ETOL GESUNDHEITSPFLEGE-UND PHARMAPRODUKTE 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.