Engelhard Arzneimittel GmbH & Co. KG
⚠️ Moderate Risk
FEI: 3003199814 • Niederdorfelden, Hassia • GERMANY
FEI Number
3003199814
Location
Niederdorfelden, Hassia
Country
GERMANYAddress
Herzberg Strasse 3, , Niederdorfelden, Hassia, 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
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).
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 |
|---|---|---|---|
| 10/8/2024 | 62GAK99ANTI-INFLAMMATORY N.E.C. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 5/13/2024 | 66VAY99MISCELLANEOUS PATENT MEDICINES, ETC. | Division of Southeast Imports (DSEI) | |
| 3/26/2024 | 66VBL99MISCELLANEOUS PATENT MEDICINES, ETC. | Division of Southeast Imports (DSEI) | |
| 2/27/2024 | 62UCK99ANTI-TUSSIVE/COLD N.E.C. | Division of Southeast Imports (DSEI) | |
| 1/4/2024 | 66FAL99SUPPRESSANT N.E.C. | Division of Southeast Imports (DSEI) | |
| 9/19/2008 | 61WBO18MICONAZOLE NITRATE (ANTI-FUNGAL) (NOT ANTIBIOTIC) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
Frequently Asked Questions
What is Engelhard Arzneimittel GmbH & Co. KG's FDA import refusal history?
Engelhard Arzneimittel GmbH & Co. KG (FEI: 3003199814) has 6 FDA import refusal record(s) in our database, spanning from 9/19/2008 to 10/8/2024.
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. Engelhard Arzneimittel GmbH & Co. KG's FEI number is 3003199814.
What types of violations has Engelhard Arzneimittel GmbH & Co. KG received?
Engelhard Arzneimittel GmbH & Co. KG 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 Engelhard Arzneimittel GmbH & Co. KG come from?
All FDA import refusal data for Engelhard Arzneimittel GmbH & Co. KG 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.