Evonik Operations GmbH
⚠️ Moderate Risk
FEI: 3002806792 • Hanau, Hassia • GERMANY
FEI Number
3002806792
Location
Hanau, Hassia
Country
GERMANYAddress
Rodenbacher Chaussee 4, , Hanau, 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
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).
DIRECTIONS
The article is subject to refusal of admission pursuant to section 801(a)(3) in that it is a device whose label appears to not bear adequate directions for use.
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.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 4/10/2025 | 61XDS50AZELASTINE HYDROCHLORIDE/FLUTICASONE, ANTI-HISTAMINE STEROID (ANTI-HISTAMINIC) | 3280FRNMFGREG | Division of Southwest Imports (DSWI) |
| 7/8/2014 | 62FLS99ANTI-INFECTIVE, TOPICAL N.E.C. | 16DIRECTIONS | Southwest Import District Office (SWI-DO) |
| 7/26/2005 | 56FBR99PEPTIDE N.E.C. | 118NOT LISTED | New Orleans District Office (NOL-DO) |
Frequently Asked Questions
What is Evonik Operations GmbH's FDA import refusal history?
Evonik Operations GmbH (FEI: 3002806792) has 3 FDA import refusal record(s) in our database, spanning from 7/26/2005 to 4/10/2025.
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. Evonik Operations GmbH's FEI number is 3002806792.
What types of violations has Evonik Operations GmbH received?
Evonik Operations 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 Evonik Operations GmbH come from?
All FDA import refusal data for Evonik Operations 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.