Sweet Tec GmbH
⚠️ High Risk
FEI: 3007179154 • Boizenburg, Mecklenburg-Western-Pommerania • GERMANY
FEI Number
3007179154
Location
Boizenburg, Mecklenburg-Western-Pommerania
Country
GERMANYAddress
Lindhorst 4, , Boizenburg, Mecklenburg-Western-Pommerania, 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
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).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 1/2/2024 | 62UBY99ANTI-TUSSIVE/COLD N.E.C. | 27DRUG GMPS | Division of Northeast Imports (DNEI) |
| 1/2/2024 | 62UBY99ANTI-TUSSIVE/COLD N.E.C. | 27DRUG GMPS | Division of Northeast Imports (DNEI) |
| 1/2/2024 | 62UBY99ANTI-TUSSIVE/COLD N.E.C. | 27DRUG GMPS | Division of Northeast Imports (DNEI) |
| 1/2/2024 | 62UBY99ANTI-TUSSIVE/COLD N.E.C. | 27DRUG GMPS | Division of Northeast Imports (DNEI) |
| 1/2/2024 | 62UBY99ANTI-TUSSIVE/COLD N.E.C. | 27DRUG GMPS | Division of Northeast Imports (DNEI) |
| 1/2/2024 | 62UBY99ANTI-TUSSIVE/COLD N.E.C. | 27DRUG GMPS | Division of Northeast Imports (DNEI) |
| 12/11/2023 | 62UBY99ANTI-TUSSIVE/COLD N.E.C. | 27DRUG GMPS | Division of Northeast Imports (DNEI) |
| 12/11/2023 | 62UBY99ANTI-TUSSIVE/COLD N.E.C. | 27DRUG GMPS | Division of Northeast Imports (DNEI) |
| 12/11/2023 | 62UBY99ANTI-TUSSIVE/COLD N.E.C. | 27DRUG GMPS | Division of Northeast Imports (DNEI) |
| 11/21/2023 | 62UBY99ANTI-TUSSIVE/COLD N.E.C. | 27DRUG GMPS | Division of Northeast Imports (DNEI) |
| 11/21/2023 | 62UBY99ANTI-TUSSIVE/COLD N.E.C. | 27DRUG GMPS | Division of Northeast Imports (DNEI) |
| 11/21/2023 | 62UBY99ANTI-TUSSIVE/COLD N.E.C. | 27DRUG GMPS | Division of Northeast Imports (DNEI) |
Frequently Asked Questions
What is Sweet Tec GmbH's FDA import refusal history?
Sweet Tec GmbH (FEI: 3007179154) has 12 FDA import refusal record(s) in our database, spanning from 11/21/2023 to 1/2/2024.
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. Sweet Tec GmbH's FEI number is 3007179154.
What types of violations has Sweet Tec GmbH received?
Sweet Tec GmbH has been cited for 1 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 Sweet Tec GmbH come from?
All FDA import refusal data for Sweet Tec 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.