B.M.P. Bulk Medicines & Pharmaceuticals GmbH
⚠️ Moderate Risk
FEI: 3002174993 • Norderstedt, Schleswig-Holstein • GERMANY
FEI Number
3002174993
Location
Norderstedt, Schleswig-Holstein
Country
GERMANYAddress
Bornbarch 16, , Norderstedt, Schleswig-Holstein, 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.
MFR INSAN
The article is subject to refusal of admission pursuant to section 801(a)(1) in that the article appears to have been manufactured, processed, or packed under insanitary conditions.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 12/8/2009 | 61GCS71SULFANILAMIDE (ANTI-BACTERIAL) (NOT ANTIBIOTIC) | 118NOT LISTED | Southwest Import District Office (SWI-DO) |
| 2/17/2005 | 60NCS15TESTOSTERONE CYPIONATE (ANDROGEN) | Southwest Import District Office (SWI-DO) | |
| 1/2/2002 | 54YYR02CARNITINE, VIT/MIN/PROTEIN/UNCONVENTIONAL DIETARY SPEC FOR HUMAN/ANIMAL, N.E.C.) | 308MFR INSAN | New York District Office (NYK-DO) |
Frequently Asked Questions
What is B.M.P. Bulk Medicines & Pharmaceuticals GmbH's FDA import refusal history?
B.M.P. Bulk Medicines & Pharmaceuticals GmbH (FEI: 3002174993) has 3 FDA import refusal record(s) in our database, spanning from 1/2/2002 to 12/8/2009.
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. B.M.P. Bulk Medicines & Pharmaceuticals GmbH's FEI number is 3002174993.
What types of violations has B.M.P. Bulk Medicines & Pharmaceuticals GmbH received?
B.M.P. Bulk Medicines & Pharmaceuticals 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 B.M.P. Bulk Medicines & Pharmaceuticals GmbH come from?
All FDA import refusal data for B.M.P. Bulk Medicines & Pharmaceuticals 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.