Brial Allergen Gmb
⚠️ Moderate Risk
FEI: 3005174015 • Greven, North Rhine-Westphalia • GERMANY
FEI Number
3005174015
Location
Greven, North Rhine-Westphalia
Country
GERMANYAddress
Bovemannstr. 8, , Greven, North Rhine-Westphalia, 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).
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.
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 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
LACKS FIRM
The article is in package form and appears to not bear a label containing the name and place of business of the manufacturer, packer, or distributor.
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 |
|---|---|---|---|
| 3/1/2016 | 80LDHSYSTEM, DELIVERY, ALLERGEN AND VACCINE | New Orleans District Office (NOL-DO) | |
| 9/5/2013 | 80LDHSYSTEM, DELIVERY, ALLERGEN AND VACCINE | New Orleans District Office (NOL-DO) | |
| 7/26/2013 | 55QP29WHITE PETROLATUM (PHARMACEUTIC NECESSITY - OLEAGINOUS) | New Orleans District Office (NOL-DO) | |
| 8/9/2012 | 80LDHSYSTEM, DELIVERY, ALLERGEN AND VACCINE | New Orleans District Office (NOL-DO) | |
| 5/24/2012 | 80LDHSYSTEM, DELIVERY, ALLERGEN AND VACCINE | New Orleans District Office (NOL-DO) | |
| 3/5/2012 | 80LDHSYSTEM, DELIVERY, ALLERGEN AND VACCINE | New Orleans District Office (NOL-DO) | |
| 1/12/2012 | 55QP29WHITE PETROLATUM (PHARMACEUTIC NECESSITY - OLEAGINOUS) | 118NOT LISTED | New Orleans District Office (NOL-DO) |
| 12/28/2011 | 80LDHSYSTEM, DELIVERY, ALLERGEN AND VACCINE | New Orleans District Office (NOL-DO) | |
| 12/13/2011 | 55QP29WHITE PETROLATUM (PHARMACEUTIC NECESSITY - OLEAGINOUS) | 16DIRECTIONS | New Orleans District Office (NOL-DO) |
| 12/12/2011 | 57GH18ALLERGEN PATCH TESTS | 71NO LICENSE | New Orleans District Office (NOL-DO) |
| 5/27/2008 | 55QP29WHITE PETROLATUM (PHARMACEUTIC NECESSITY - OLEAGINOUS) | 118NOT LISTED | New Orleans District Office (NOL-DO) |
| 3/12/2008 | 55QP29WHITE PETROLATUM (PHARMACEUTIC NECESSITY - OLEAGINOUS) | 118NOT LISTED | New Orleans District Office (NOL-DO) |
| 3/12/2008 | 55QP29WHITE PETROLATUM (PHARMACEUTIC NECESSITY - OLEAGINOUS) | 118NOT LISTED | New Orleans District Office (NOL-DO) |
| 3/12/2008 | 55QP29WHITE PETROLATUM (PHARMACEUTIC NECESSITY - OLEAGINOUS) | 118NOT LISTED | New Orleans District Office (NOL-DO) |
| 3/12/2008 | 55QP29WHITE PETROLATUM (PHARMACEUTIC NECESSITY - OLEAGINOUS) | 118NOT LISTED | New Orleans District Office (NOL-DO) |
| 9/4/2007 | 57GB02ALLERGENIC EXTRACTS ALUM PRECIPITATED (ALLERGENIC PRODUCTS) | New Orleans District Office (NOL-DO) |
Frequently Asked Questions
What is Brial Allergen Gmb's FDA import refusal history?
Brial Allergen Gmb (FEI: 3005174015) has 16 FDA import refusal record(s) in our database, spanning from 9/4/2007 to 3/1/2016.
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. Brial Allergen Gmb's FEI number is 3005174015.
What types of violations has Brial Allergen Gmb received?
Brial Allergen Gmb has been cited for 7 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 Brial Allergen Gmb come from?
All FDA import refusal data for Brial Allergen Gmb 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.