Biesterfeld Siemsgluss
⚠️ Moderate Risk
FEI: 3003074214 • Hamburg, Hamburg • GERMANY
FEI Number
3003074214
Location
Hamburg, Hamburg
Country
GERMANYAddress
Ferdinandstr. 41, , Hamburg, Hamburg, 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).
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).
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.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 3/16/2006 | 61GCS57SULFAMETHOXAZOLE (ANTI-BACTERIAL) (NOT ANTIBIOTIC) | 75UNAPPROVED | Florida District Office (FLA-DO) |
| 3/16/2006 | 56EYS99TETRACYCLINE N.E.C. | 75UNAPPROVED | Florida District Office (FLA-DO) |
| 12/5/2005 | 56EYS99TETRACYCLINE N.E.C. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 8/17/2005 | 61GCS57SULFAMETHOXAZOLE (ANTI-BACTERIAL) (NOT ANTIBIOTIC) | 75UNAPPROVED | Florida District Office (FLA-DO) |
| 8/17/2005 | 61HCS03TRIMETHOPRIM (ANTI-BACTERIAL) | 75UNAPPROVED | Florida District Office (FLA-DO) |
| 5/26/2005 | 64MAS01CLOMIPHENE CITRATE (GONAD-STIMULATING PRINCIPLE) | 75UNAPPROVED | Florida District Office (FLA-DO) |
| 5/26/2005 | 60WAS18NICLOSAMIDE (ANTHELMINTIC) | 75UNAPPROVED | Florida District Office (FLA-DO) |
| 4/13/2005 | 61HCS03TRIMETHOPRIM (ANTI-BACTERIAL) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 4/13/2005 | 56EYS99TETRACYCLINE N.E.C. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 7/22/2004 | 61HCS03TRIMETHOPRIM (ANTI-BACTERIAL) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 7/22/2004 | 62GCY41IBUPROFEN (ANTI-INFLAMMATORY) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 1/12/2004 | 56EYS99TETRACYCLINE N.E.C. | 118NOT LISTED | Division of Southeast Imports (DSEI) |
| 7/25/2003 | 61HCS03TRIMETHOPRIM (ANTI-BACTERIAL) | 118NOT LISTED | Florida District Office (FLA-DO) |
| 7/25/2003 | 56EYS99TETRACYCLINE N.E.C. | 118NOT LISTED | Florida District Office (FLA-DO) |
| 5/15/2003 | 61HAS18AMINOSALICYLIC ACID (ANTI-BACTERIAL) | 118NOT LISTED | Florida District Office (FLA-DO) |
| 5/15/2003 | 61TAS12METOCLOPRAMIDE HCL (ANTI-EMETIC/NAUSEANT) | 118NOT LISTED | Florida District Office (FLA-DO) |
| 5/15/2003 | 63DAS06PROPAZOLAMIDE (CARBONIC ANHYDRASE INHIBITOR) | 118NOT LISTED | Florida District Office (FLA-DO) |
| 5/15/2003 | 56KAS70RIFAMPIN | 118NOT LISTED | Florida District Office (FLA-DO) |
| 5/15/2003 | 56IAS35ERYTHROMYCIN STEARATE (MACROLIDES) | 118NOT LISTED | Florida District Office (FLA-DO) |
| 5/15/2003 | 61HCS03TRIMETHOPRIM (ANTI-BACTERIAL) | 118NOT LISTED | Florida District Office (FLA-DO) |
| 2/10/2003 | 56EYS99TETRACYCLINE N.E.C. | 118NOT LISTED | Florida District Office (FLA-DO) |
| 2/10/2003 | 61HCR03TRIMETHOPRIM (ANTI-BACTERIAL) | 118NOT LISTED | Florida District Office (FLA-DO) |
| 12/2/2002 | 62IDS18DROMOSTANOLONE PROPIONATE (ANTI-NEOPLASTIC) | 118NOT LISTED | Florida District Office (FLA-DO) |
| 11/6/2002 | 64BAS25HYDROCHLOROTHIAZIDE (DIURETIC) | 118NOT LISTED | Florida District Office (FLA-DO) |
| 11/6/2002 | 61HAS24ISONIAZID (ANTI-BACTERIAL) | 118NOT LISTED | Florida District Office (FLA-DO) |
| 10/2/2002 | 61LDU08HEPARIN SODIUM (ANTI-COAGULANT) | 16DIRECTIONS | New York District Office (NYK-DO) |
| 3/22/2002 | 60WDS01ALBENDAZOLE (ANTHELMINTIC) | 118NOT LISTED | Florida District Office (FLA-DO) |
| 3/22/2002 | 61TAS12METOCLOPRAMIDE HCL (ANTI-EMETIC/NAUSEANT) | 118NOT LISTED | Florida District Office (FLA-DO) |
| 10/17/2001 | 56EYS80TETRACYCLINE (TETRACYCLINES) | 118NOT LISTED | Florida District Office (FLA-DO) |
Frequently Asked Questions
What is Biesterfeld Siemsgluss's FDA import refusal history?
Biesterfeld Siemsgluss (FEI: 3003074214) has 29 FDA import refusal record(s) in our database, spanning from 10/17/2001 to 3/16/2006.
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. Biesterfeld Siemsgluss's FEI number is 3003074214.
What types of violations has Biesterfeld Siemsgluss received?
Biesterfeld Siemsgluss 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 Biesterfeld Siemsgluss come from?
All FDA import refusal data for Biesterfeld Siemsgluss 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.