Bionorica Ag
⚠️ Moderate Risk
FEI: 3004097876 • Neumarkt i.d.OPf., Bavaria • GERMANY
FEI Number
3004097876
Location
Neumarkt i.d.OPf., Bavaria
Country
GERMANYAddress
Kerschensteinerstr. 11-15, , Neumarkt i.d.OPf., Bavaria, 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).
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).
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.
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).
NO ENGLISH
Required label or labeling appears to not be in English in violation of 21 C.F.R. 801.15(c)(1)
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 3/9/2023 | 66YBL99EXHIBITS - OTHER DRUG RELATED ITEMS N.E.C. | Division of Northeast Imports (DNEI) | |
| 3/9/2023 | 66YBA99EXHIBITS - OTHER DRUG RELATED ITEMS N.E.C. | Division of Northeast Imports (DNEI) | |
| 3/9/2023 | 66YBL99EXHIBITS - OTHER DRUG RELATED ITEMS N.E.C. | Division of Northeast Imports (DNEI) | |
| 3/9/2023 | 62UBL99ANTI-TUSSIVE/COLD N.E.C. | Division of Northeast Imports (DNEI) | |
| 6/22/2021 | 54AGA99VITAMIN, N.E.C. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 11/26/2018 | 62GCA99ANTI-INFLAMMATORY N.E.C. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 5/24/2017 | 66YBA99EXHIBITS - OTHER DRUG RELATED ITEMS N.E.C. | Division of Northeast Imports (DNEI) | |
| 5/23/2017 | 62GDL99ANTI-INFLAMMATORY N.E.C. | Division of Northeast Imports (DNEI) | |
| 5/23/2017 | 62GDL99ANTI-INFLAMMATORY N.E.C. | Division of Northeast Imports (DNEI) | |
| 5/23/2017 | 62GDL99ANTI-INFLAMMATORY N.E.C. | Division of Northeast Imports (DNEI) | |
| 5/22/2017 | 66YBL99EXHIBITS - OTHER DRUG RELATED ITEMS N.E.C. | Division of Northeast Imports (DNEI) | |
| 7/27/2015 | 61MAL99ANTI-CONVULSANT, N.E.C. | Division of Northeast Imports (DNEI) |
Frequently Asked Questions
What is Bionorica Ag's FDA import refusal history?
Bionorica Ag (FEI: 3004097876) has 12 FDA import refusal record(s) in our database, spanning from 7/27/2015 to 3/9/2023.
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. Bionorica Ag's FEI number is 3004097876.
What types of violations has Bionorica Ag received?
Bionorica Ag has been cited for 6 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 Bionorica Ag come from?
All FDA import refusal data for Bionorica Ag 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.