Helixor Heilmittel GmbH
⚠️ High Risk
FEI: 3004102645 • Rosenfeld, Baden-Wurttemberg • GERMANY
FEI Number
3004102645
Location
Rosenfeld, Baden-Wurttemberg
Country
GERMANYAddress
Fischermuhle 1, , Rosenfeld, Baden-Wurttemberg, Germany
High Risk
FDA Import Risk Assessment
This firm has a significant history of FDA import refusals with notable 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
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).
DRUG GMPS
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the methods used in and controls used for the manufacture, processing, packing, or holding of drugs and other products do not appear to conform to current good manufacturing practices within the meaning of Section 501(a)(2)(B).
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).
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 |
|---|---|---|---|
| 4/21/2023 | 66VCY99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 12/4/2017 | 62IDL99ANTI-NEOPLASTIC N.E.C. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 8/25/2017 | 66VCP99MISCELLANEOUS PATENT MEDICINES, ETC. | 27DRUG GMPS | Division of Southeast Imports (DSEI) |
| 8/24/2017 | 66VCP99MISCELLANEOUS PATENT MEDICINES, ETC. | 27DRUG GMPS | Division of Southeast Imports (DSEI) |
| 8/24/2017 | 66VCP99MISCELLANEOUS PATENT MEDICINES, ETC. | 27DRUG GMPS | Division of Southeast Imports (DSEI) |
| 8/22/2017 | 66VCP99MISCELLANEOUS PATENT MEDICINES, ETC. | 27DRUG GMPS | Division of Southeast Imports (DSEI) |
| 4/21/2017 | 66VDY99MISCELLANEOUS PATENT MEDICINES, ETC. | Division of Southeast Imports (DSEI) | |
| 2/2/2016 | 55PY23SODIUM HYDROXIDE (PHARMACEUTIC NECESSITY - ALKALIZING AGENT) | Cincinnati District Office (CIN-DO) | |
| 10/21/2015 | 66YCK99EXHIBITS - OTHER DRUG RELATED ITEMS N.E.C. | 75UNAPPROVED | Division of Northern Border Imports (DNBI) |
| 6/16/2014 | 66VDP99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | Philadelphia District Office (PHI-DO) |
| 6/16/2014 | 66VDP99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | Philadelphia District Office (PHI-DO) |
| 1/26/2004 | 66VBY99MISCELLANEOUS PATENT MEDICINES, ETC. | Cincinnati District Office (CIN-DO) |
Frequently Asked Questions
What is Helixor Heilmittel GmbH's FDA import refusal history?
Helixor Heilmittel GmbH (FEI: 3004102645) has 12 FDA import refusal record(s) in our database, spanning from 1/26/2004 to 4/21/2023.
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. Helixor Heilmittel GmbH's FEI number is 3004102645.
What types of violations has Helixor Heilmittel GmbH received?
Helixor Heilmittel 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 Helixor Heilmittel GmbH come from?
All FDA import refusal data for Helixor Heilmittel 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.