Dental-Kosmetik GmbH & Co. KG
⚠️ Moderate Risk
FEI: 3001623034 • Dresden, Saxony • GERMANY
FEI Number
3001623034
Location
Dresden, Saxony
Country
GERMANYAddress
Katharinenstr. 4, , Dresden, Saxony, 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
DRUG GMPS
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the methods used in and controls used for the manufacture, processing, packing, or holding of drugs and other products do not appear to conform to current good manufacturing practices within the meaning of Section 501(a)(2)(B).
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.
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 |
|---|---|---|---|
| 2/14/2020 | 63RBY06STANNOUS FLUORIDE (DENTAL CARIES PROPHYLACTIC) | 27DRUG GMPS | Division of Northeast Imports (DNEI) |
| 2/14/2020 | 63RBY06STANNOUS FLUORIDE (DENTAL CARIES PROPHYLACTIC) | 27DRUG GMPS | Division of Northeast Imports (DNEI) |
| 2/14/2020 | 63RBY06STANNOUS FLUORIDE (DENTAL CARIES PROPHYLACTIC) | 27DRUG GMPS | Division of Northeast Imports (DNEI) |
| 2/14/2020 | 63RBY06STANNOUS FLUORIDE (DENTAL CARIES PROPHYLACTIC) | 27DRUG GMPS | Division of Northeast Imports (DNEI) |
| 2/14/2020 | 63RBY06STANNOUS FLUORIDE (DENTAL CARIES PROPHYLACTIC) | 27DRUG GMPS | Division of Northeast Imports (DNEI) |
| 2/14/2020 | 63RBY06STANNOUS FLUORIDE (DENTAL CARIES PROPHYLACTIC) | 27DRUG GMPS | Division of Northeast Imports (DNEI) |
| 2/14/2020 | 63RBY06STANNOUS FLUORIDE (DENTAL CARIES PROPHYLACTIC) | 27DRUG GMPS | Division of Northeast Imports (DNEI) |
| 2/11/2008 | 63RBY06STANNOUS FLUORIDE (DENTAL CARIES PROPHYLACTIC) | Detroit District Office (DET-DO) |
Frequently Asked Questions
What is Dental-Kosmetik GmbH & Co. KG's FDA import refusal history?
Dental-Kosmetik GmbH & Co. KG (FEI: 3001623034) has 8 FDA import refusal record(s) in our database, spanning from 2/11/2008 to 2/14/2020.
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. Dental-Kosmetik GmbH & Co. KG's FEI number is 3001623034.
What types of violations has Dental-Kosmetik GmbH & Co. KG received?
Dental-Kosmetik GmbH & Co. KG 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 Dental-Kosmetik GmbH & Co. KG come from?
All FDA import refusal data for Dental-Kosmetik GmbH & Co. KG 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.