Biotest Medical Diagnostics Gmbh
⚠️ High Risk
FEI: 3006975392 • Dreieich, Hesse • GERMANY
FEI Number
3006975392
Location
Dreieich, Hesse
Country
GERMANYAddress
Postfach 102150, Industriestrasse 1D 63303, Dreieich, Hesse, Germany
High Risk
FDA Import Risk Assessment
This firm has a significant history of FDA import refusals with notable violations.
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
NO LICENSE
The article is subject to refusal of admission under section 801(a)(3) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) because it appears to be a biological product for which a biologics license is not in effect under the Public Health Service Act, Part F, Subpart 1-Biological Products, Section 351(a), and it is not the subject of an Investigational New Drug application that is in effect. Therefore, it appears to be a new drug under 201(p) of the FD&C Act that it is in violation of section 505(a) of the FD&C Act because it lacks a new drug approval and because it is misbranded under section 502(f)(1)of the FD&C Act because it fails to bear adequate directions for use
DIRSEXMPT
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be a drug within the meaning of Section 201(g) and it lacks adequate directions for use.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 5/26/2009 | 57FG69ANTI-N (RABBIT) (BLOOD GROUPING SERUM) | 71NO LICENSE | New York District Office (NYK-DO) |
| 5/26/2009 | 57FG68ANTI-M (RABBIT) (BLOOD GROUPING SERUM) | 71NO LICENSE | New York District Office (NYK-DO) |
| 5/26/2009 | 57FG13ANTI-JKB (BLOOD GROUPING SERUM) | 71NO LICENSE | New York District Office (NYK-DO) |
| 5/26/2009 | 57FG12ANTI-JKA (BLOOD GROUPING SERUM) | 71NO LICENSE | New York District Office (NYK-DO) |
| 5/26/2009 | 57FG12ANTI-JKA (BLOOD GROUPING SERUM) | 71NO LICENSE | New York District Office (NYK-DO) |
| 5/26/2009 | 57FG16ANTI-K (CAPITAL K) (BLOOD GROUPING SERUM) | 71NO LICENSE | New York District Office (NYK-DO) |
| 5/26/2009 | 57FG64ANTI-E (SMALL E) (SALINE ACTIVE) (BLOOD GROUPING SERUM) | 71NO LICENSE | New York District Office (NYK-DO) |
| 5/26/2009 | 57FG63ANTI-C (SMALL C) (SALINE ACTIVE) (BLOOD GROUPING SERUM) | 71NO LICENSE | New York District Office (NYK-DO) |
| 5/26/2009 | 57FG62ANTI-E (SALINE ACTIVE) (BLOOD GROUPING SERUM) | 71NO LICENSE | New York District Office (NYK-DO) |
| 5/26/2009 | 57FG65ANTI-CW (SALINE ACTIVE) (BLOOD GROUPING SERUM) | 71NO LICENSE | New York District Office (NYK-DO) |
| 5/26/2009 | 57FG03ANTI-B (BLOOD GROUPING SERUM) | 71NO LICENSE | New York District Office (NYK-DO) |
| 5/26/2009 | 57FG02ANTI-A (BLOOD GROUPING SERUM) | 71NO LICENSE | New York District Office (NYK-DO) |
| 5/22/2009 | 57FG69ANTI-N (RABBIT) (BLOOD GROUPING SERUM) | 2280DIRSEXMPT | New York District Office (NYK-DO) |
| 5/22/2009 | 57FG68ANTI-M (RABBIT) (BLOOD GROUPING SERUM) | 2280DIRSEXMPT | New York District Office (NYK-DO) |
| 5/22/2009 | 57FG21ANTI-LUA (BLOOD GROUPING SERUM) | 2280DIRSEXMPT | New York District Office (NYK-DO) |
| 5/22/2009 | 57FG13ANTI-JKB (BLOOD GROUPING SERUM) | 2280DIRSEXMPT | New York District Office (NYK-DO) |
| 5/22/2009 | 57FG12ANTI-JKA (BLOOD GROUPING SERUM) | 2280DIRSEXMPT | New York District Office (NYK-DO) |
| 5/22/2009 | 57FG70ANTI_P1 (GOAT) (BLOOD GROUPING SERUM) | 2280DIRSEXMPT | New York District Office (NYK-DO) |
| 5/22/2009 | 57FG17ANTI-KPA (BLOOD GROUPING SERUM) | 2280DIRSEXMPT | New York District Office (NYK-DO) |
| 5/22/2009 | 57FG16ANTI-K (CAPITAL K) (BLOOD GROUPING SERUM) | 2280DIRSEXMPT | New York District Office (NYK-DO) |
| 5/22/2009 | 57FG38ANTI-S (BLOOD GROUPING SERUM) | 2280DIRSEXMPT | New York District Office (NYK-DO) |
| 5/22/2009 | 57FG64ANTI-E (SMALL E) (SALINE ACTIVE) (BLOOD GROUPING SERUM) | 2280DIRSEXMPT | New York District Office (NYK-DO) |
| 5/22/2009 | 57FG63ANTI-C (SMALL C) (SALINE ACTIVE) (BLOOD GROUPING SERUM) | 2280DIRSEXMPT | New York District Office (NYK-DO) |
| 5/22/2009 | 57FG62ANTI-E (SALINE ACTIVE) (BLOOD GROUPING SERUM) | 2280DIRSEXMPT | New York District Office (NYK-DO) |
| 5/22/2009 | 57FG63ANTI-C (SMALL C) (SALINE ACTIVE) (BLOOD GROUPING SERUM) | 2280DIRSEXMPT | New York District Office (NYK-DO) |
| 5/22/2009 | 57FG65ANTI-CW (SALINE ACTIVE) (BLOOD GROUPING SERUM) | 2280DIRSEXMPT | New York District Office (NYK-DO) |
| 5/22/2009 | 57FG28ANTI-D (HIGH PROTEIN) (BLOOD GROUPING SERUM) | 2280DIRSEXMPT | New York District Office (NYK-DO) |
| 5/22/2009 | 57FG04ANTI-A,B (BLOOD GROUPING SERUM) | 2280DIRSEXMPT | New York District Office (NYK-DO) |
| 5/22/2009 | 57FG03ANTI-B (BLOOD GROUPING SERUM) | 2280DIRSEXMPT | New York District Office (NYK-DO) |
| 5/22/2009 | 57FG02ANTI-A (BLOOD GROUPING SERUM) | 2280DIRSEXMPT | New York District Office (NYK-DO) |
| 5/22/2009 | 57FG01ANTI-A1 (BLOOD GROUPING SERUM) | 71NO LICENSE | New York District Office (NYK-DO) |
| 5/22/2009 | 57FG69ANTI-N (RABBIT) (BLOOD GROUPING SERUM) | 71NO LICENSE | New York District Office (NYK-DO) |
| 5/22/2009 | 57FG68ANTI-M (RABBIT) (BLOOD GROUPING SERUM) | 71NO LICENSE | New York District Office (NYK-DO) |
| 5/22/2009 | 57FG13ANTI-JKB (BLOOD GROUPING SERUM) | 71NO LICENSE | New York District Office (NYK-DO) |
| 5/22/2009 | 57FG12ANTI-JKA (BLOOD GROUPING SERUM) | 71NO LICENSE | New York District Office (NYK-DO) |
| 5/22/2009 | 57FG70ANTI_P1 (GOAT) (BLOOD GROUPING SERUM) | 71NO LICENSE | New York District Office (NYK-DO) |
| 5/22/2009 | 57FG17ANTI-KPA (BLOOD GROUPING SERUM) | 71NO LICENSE | New York District Office (NYK-DO) |
| 5/22/2009 | 57FG16ANTI-K (CAPITAL K) (BLOOD GROUPING SERUM) | 71NO LICENSE | New York District Office (NYK-DO) |
| 5/22/2009 | 57FG39ANTI-S (SMALL S) (BLOOD GROUPING SERUM) | 71NO LICENSE | New York District Office (NYK-DO) |
| 5/22/2009 | 57FG38ANTI-S (BLOOD GROUPING SERUM) | 71NO LICENSE | New York District Office (NYK-DO) |
| 5/22/2009 | 57FG09ANTI-HUMAN SERUM (IN-VITRO DIAGNOSTIC PRODUCTS) | 71NO LICENSE | New York District Office (NYK-DO) |
| 5/22/2009 | 57FG64ANTI-E (SMALL E) (SALINE ACTIVE) (BLOOD GROUPING SERUM) | 71NO LICENSE | New York District Office (NYK-DO) |
| 5/22/2009 | 57FG63ANTI-C (SMALL C) (SALINE ACTIVE) (BLOOD GROUPING SERUM) | 71NO LICENSE | New York District Office (NYK-DO) |
| 5/22/2009 | 57FG62ANTI-E (SALINE ACTIVE) (BLOOD GROUPING SERUM) | 71NO LICENSE | New York District Office (NYK-DO) |
| 5/22/2009 | 57FG61ANTI-C (SALINE ACTIVE) (BLOOD GROUPING SERUM) | 71NO LICENSE | New York District Office (NYK-DO) |
| 5/22/2009 | 57FG65ANTI-CW (SALINE ACTIVE) (BLOOD GROUPING SERUM) | 71NO LICENSE | New York District Office (NYK-DO) |
| 5/22/2009 | 57FG28ANTI-D (HIGH PROTEIN) (BLOOD GROUPING SERUM) | 71NO LICENSE | New York District Office (NYK-DO) |
| 5/22/2009 | 57FG03ANTI-B (BLOOD GROUPING SERUM) | 71NO LICENSE | New York District Office (NYK-DO) |
| 5/22/2009 | 57FG02ANTI-A (BLOOD GROUPING SERUM) | 71NO LICENSE | New York District Office (NYK-DO) |
| 5/22/2009 | 57FG61ANTI-C (SALINE ACTIVE) (BLOOD GROUPING SERUM) | 71NO LICENSE | New York District Office (NYK-DO) |
| 5/22/2009 | 57FG69ANTI-N (RABBIT) (BLOOD GROUPING SERUM) | 71NO LICENSE | New York District Office (NYK-DO) |
| 5/22/2009 | 57FG68ANTI-M (RABBIT) (BLOOD GROUPING SERUM) | 71NO LICENSE | New York District Office (NYK-DO) |
| 5/22/2009 | 57FG21ANTI-LUA (BLOOD GROUPING SERUM) | 71NO LICENSE | New York District Office (NYK-DO) |
| 5/22/2009 | 57FG12ANTI-JKA (BLOOD GROUPING SERUM) | 71NO LICENSE | New York District Office (NYK-DO) |
| 5/22/2009 | 57FG17ANTI-KPA (BLOOD GROUPING SERUM) | 71NO LICENSE | New York District Office (NYK-DO) |
| 5/22/2009 | 57FG38ANTI-S (BLOOD GROUPING SERUM) | 71NO LICENSE | New York District Office (NYK-DO) |
| 5/22/2009 | 57FG64ANTI-E (SMALL E) (SALINE ACTIVE) (BLOOD GROUPING SERUM) | 71NO LICENSE | New York District Office (NYK-DO) |
| 5/22/2009 | 57FG63ANTI-C (SMALL C) (SALINE ACTIVE) (BLOOD GROUPING SERUM) | 71NO LICENSE | New York District Office (NYK-DO) |
| 5/22/2009 | 57FG62ANTI-E (SALINE ACTIVE) (BLOOD GROUPING SERUM) | 71NO LICENSE | New York District Office (NYK-DO) |
| 5/22/2009 | 57FG31ANTI-CDE (HIGH PROTEIN) (BLOOD GROUPING SERUM) | 71NO LICENSE | New York District Office (NYK-DO) |
| 5/22/2009 | 57FG28ANTI-D (HIGH PROTEIN) (BLOOD GROUPING SERUM) | 71NO LICENSE | New York District Office (NYK-DO) |
| 5/22/2009 | 57FG04ANTI-A,B (BLOOD GROUPING SERUM) | 71NO LICENSE | New York District Office (NYK-DO) |
| 5/22/2009 | 57FG03ANTI-B (BLOOD GROUPING SERUM) | 71NO LICENSE | New York District Office (NYK-DO) |
| 5/22/2009 | 57FG02ANTI-A (BLOOD GROUPING SERUM) | 71NO LICENSE | New York District Office (NYK-DO) |
| 5/22/2009 | 57FG12ANTI-JKA (BLOOD GROUPING SERUM) | 71NO LICENSE | New York District Office (NYK-DO) |
| 5/22/2009 | 57FG70ANTI_P1 (GOAT) (BLOOD GROUPING SERUM) | 71NO LICENSE | New York District Office (NYK-DO) |
| 5/22/2009 | 57FG16ANTI-K (CAPITAL K) (BLOOD GROUPING SERUM) | 71NO LICENSE | New York District Office (NYK-DO) |
| 5/22/2009 | 57FG38ANTI-S (BLOOD GROUPING SERUM) | 71NO LICENSE | New York District Office (NYK-DO) |
| 5/22/2009 | 57FG64ANTI-E (SMALL E) (SALINE ACTIVE) (BLOOD GROUPING SERUM) | 71NO LICENSE | New York District Office (NYK-DO) |
| 5/22/2009 | 57FG63ANTI-C (SMALL C) (SALINE ACTIVE) (BLOOD GROUPING SERUM) | 71NO LICENSE | New York District Office (NYK-DO) |
| 5/22/2009 | 57FG62ANTI-E (SALINE ACTIVE) (BLOOD GROUPING SERUM) | 71NO LICENSE | New York District Office (NYK-DO) |
| 5/22/2009 | 57FG61ANTI-C (SALINE ACTIVE) (BLOOD GROUPING SERUM) | 71NO LICENSE | New York District Office (NYK-DO) |
| 5/22/2009 | 57FG65ANTI-CW (SALINE ACTIVE) (BLOOD GROUPING SERUM) | 71NO LICENSE | New York District Office (NYK-DO) |
| 5/22/2009 | 57FG31ANTI-CDE (HIGH PROTEIN) (BLOOD GROUPING SERUM) | 71NO LICENSE | New York District Office (NYK-DO) |
| 5/22/2009 | 57FG28ANTI-D (HIGH PROTEIN) (BLOOD GROUPING SERUM) | 71NO LICENSE | New York District Office (NYK-DO) |
| 5/22/2009 | 57FG04ANTI-A,B (BLOOD GROUPING SERUM) | 71NO LICENSE | New York District Office (NYK-DO) |
| 5/22/2009 | 57FG03ANTI-B (BLOOD GROUPING SERUM) | 71NO LICENSE | New York District Office (NYK-DO) |
Frequently Asked Questions
What is Biotest Medical Diagnostics Gmbh's FDA import refusal history?
Biotest Medical Diagnostics Gmbh (FEI: 3006975392) has 77 FDA import refusal record(s) in our database, spanning from 5/22/2009 to 5/26/2009.
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. Biotest Medical Diagnostics Gmbh's FEI number is 3006975392.
What types of violations has Biotest Medical Diagnostics Gmbh received?
Biotest Medical Diagnostics Gmbh has been cited for 2 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 Biotest Medical Diagnostics Gmbh come from?
All FDA import refusal data for Biotest Medical Diagnostics 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.