Regenaplex Homoopathische
⚠️ Moderate Risk
FEI: 3005673253 • Constance • GERMANY
FEI Number
3005673253
Location
Constance
Country
GERMANYAddress
Robert-Bosch-Str.3, , Constance, , 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
DANGEROUS
The article appears to be dangerous to health when used in the dosage or manner, or with the frequency or duration, prescribed, recommended, or suggested in the labeling thereof.
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
Frequently Asked Questions
What is Regenaplex Homoopathische's FDA import refusal history?
Regenaplex Homoopathische (FEI: 3005673253) has 1 FDA import refusal record(s) in our database, spanning from 5/2/2006 to 5/2/2006.
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. Regenaplex Homoopathische's FEI number is 3005673253.
What types of violations has Regenaplex Homoopathische received?
Regenaplex Homoopathische has been cited for 2 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 Regenaplex Homoopathische come from?
All FDA import refusal data for Regenaplex Homoopathische 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.