Colostrum BioTec GmbH
⚠️ Moderate Risk
FEI: 3013570052 • Konigsbrunn, Bavaria • GERMANY
FEI Number
3013570052
Location
Konigsbrunn, Bavaria
Country
GERMANYAddress
Richthofenstr. 21 1/2, , Konigsbrunn, 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
DIETARYLBL
The article is subject to refusal of admission pursuant to Section 801(a)(3) of the FD&C Act in that it is a dietary supplement that appears to be misbranded within the meaning of Section 403(s)(2)(B) of the FD&C Act in that the label or labeling fails to identify the product by using the term "dietary supplement", which term may be modified with the name of such an ingredient.
PLANT PART
The article is subject to refusal of admission pursuant to Section 801(a)(3) of the FD&C Act in that it is a dietary supplement that appears to be misbranded within the meaning of Section 403(s)(2)(C) of the FD&C Act in that the supplement contains an herb or other botanical described in section 201(ff)(1)(C), and the label or labeling of the supplement fails to identify any part of the plant from which the ingredient is derived.
NUTRIT LBL
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be misbranded in that the label or labeling fails to bear the required nutrition information.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 11/20/2015 | 66YBH99EXHIBITS - OTHER DRUG RELATED ITEMS N.E.C. | Division of Southeast Imports (DSEI) | |
| 11/20/2015 | 54YYK99VITAMIN, MINERAL, PROTEINS AND UNCONVENTIONAL DIETARY SPECIALITIES FOR HUMANS AND ANIMALS, N.E.C. | Division of Southeast Imports (DSEI) | |
| 11/20/2015 | 66YBH99EXHIBITS - OTHER DRUG RELATED ITEMS N.E.C. | Division of Southeast Imports (DSEI) |
Frequently Asked Questions
What is Colostrum BioTec GmbH's FDA import refusal history?
Colostrum BioTec GmbH (FEI: 3013570052) has 3 FDA import refusal record(s) in our database, spanning from 11/20/2015 to 11/20/2015.
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. Colostrum BioTec GmbH's FEI number is 3013570052.
What types of violations has Colostrum BioTec GmbH received?
Colostrum BioTec GmbH 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 Colostrum BioTec GmbH come from?
All FDA import refusal data for Colostrum BioTec 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.