ABX Advanced Biochemical Compounds Biomedizinische Forschungsreagenzien GmbH
⚠️ Moderate Risk
FEI: 3004849998 • Radeberg, Saxony • GERMANY
FEI Number
3004849998
Location
Radeberg, Saxony
Country
GERMANYAddress
Heinrich-Glaser-Str. 10-14, , Radeberg, Saxony, 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.
NO 510(K)
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it is a post 1976 device for which a Section 510(k)application does not appear to have been determined substantially equivalent or otherwise filed.
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).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 11/3/2016 | 66VIL99MISCELLANEOUS PATENT MEDICINES, ETC. | 16DIRECTIONS | Philadelphia District Office (PHI-DO) |
| 5/2/2016 | 62TIK04OCTREOTIDE ACETATE (ANTI-SECRETORY) | Division of Northeast Imports (DNEI) | |
| 9/13/2011 | 74DXTINJECTOR AND SYRINGE, ANGIOGRAPHIC | New Orleans District Office (NOL-DO) |
Frequently Asked Questions
What is ABX Advanced Biochemical Compounds Biomedizinische Forschungsreagenzien GmbH's FDA import refusal history?
ABX Advanced Biochemical Compounds Biomedizinische Forschungsreagenzien GmbH (FEI: 3004849998) has 3 FDA import refusal record(s) in our database, spanning from 9/13/2011 to 11/3/2016.
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. ABX Advanced Biochemical Compounds Biomedizinische Forschungsreagenzien GmbH's FEI number is 3004849998.
What types of violations has ABX Advanced Biochemical Compounds Biomedizinische Forschungsreagenzien GmbH received?
ABX Advanced Biochemical Compounds Biomedizinische Forschungsreagenzien GmbH has been cited for 5 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 ABX Advanced Biochemical Compounds Biomedizinische Forschungsreagenzien GmbH come from?
All FDA import refusal data for ABX Advanced Biochemical Compounds Biomedizinische Forschungsreagenzien 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.