Gaba Gmbh
⚠️ Moderate Risk
FEI: 3006118127 • Lorrach, Baden-Wurttemberg • GERMANY
FEI Number
3006118127
Location
Lorrach, Baden-Wurttemberg
Country
GERMANYAddress
Berner Weg 7, , Lorrach, Baden-Wurttemberg, 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.
NO ENGLISH
Required label or labeling appears to not be in English in violation of 21 C.F.R. 201.15(c)(1).
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.
LABELING
The article appears in violation of FPLA because of its placement, form and/or contents statement.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 5/7/2014 | 63RKY06STANNOUS FLUORIDE (DENTAL CARIES PROPHYLACTIC) | Cincinnati District Office (CIN-DO) | |
| 11/21/2012 | 63RBL06STANNOUS FLUORIDE (DENTAL CARIES PROPHYLACTIC) | New York District Office (NYK-DO) | |
| 11/21/2012 | 63RBL04SODIUM FLUORIDE (DENTAL CARIES PROPHYLACTIC) | New York District Office (NYK-DO) | |
| 11/21/2012 | 63RBL99DENTAL CARIES PROPHYLACTIC N.E.C. | New York District Office (NYK-DO) | |
| 11/21/2012 | 63RBL99DENTAL CARIES PROPHYLACTIC N.E.C. | New York District Office (NYK-DO) | |
| 11/21/2012 | 63RBL04SODIUM FLUORIDE (DENTAL CARIES PROPHYLACTIC) | New York District Office (NYK-DO) | |
| 11/21/2012 | 63RBL99DENTAL CARIES PROPHYLACTIC N.E.C. | New York District Office (NYK-DO) | |
| 11/21/2012 | 63RBL99DENTAL CARIES PROPHYLACTIC N.E.C. | 118NOT LISTED | New York District Office (NYK-DO) |
| 6/19/2012 | 63RCY06STANNOUS FLUORIDE (DENTAL CARIES PROPHYLACTIC) | New Orleans District Office (NOL-DO) | |
| 10/7/2011 | 63RBY06STANNOUS FLUORIDE (DENTAL CARIES PROPHYLACTIC) | 472NO ENGLISH | New Orleans District Office (NOL-DO) |
| 8/29/2011 | 53IY01DENTIFRICES (AEROSOL, LIQUID, TOOTHPASTES, TOOTHPOWDERS), WITHOUT FLUORIDE (ORAL HYGIENE PRODUCTS) | 473LABELING | New Orleans District Office (NOL-DO) |
| 8/29/2011 | 63RBJ06STANNOUS FLUORIDE (DENTAL CARIES PROPHYLACTIC) | New Orleans District Office (NOL-DO) | |
| 8/29/2011 | 63RBJ06STANNOUS FLUORIDE (DENTAL CARIES PROPHYLACTIC) | New Orleans District Office (NOL-DO) |
Frequently Asked Questions
What is Gaba Gmbh's FDA import refusal history?
Gaba Gmbh (FEI: 3006118127) has 13 FDA import refusal record(s) in our database, spanning from 8/29/2011 to 5/7/2014.
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. Gaba Gmbh's FEI number is 3006118127.
What types of violations has Gaba Gmbh received?
Gaba Gmbh has been cited for 5 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 Gaba Gmbh come from?
All FDA import refusal data for Gaba 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.