Dragenopharm Apotheker Pueschl GmbH
⚠️ High Risk
FEI: 3009943598 • Tittmoning, Bavaria • GERMANY
FEI Number
3009943598
Location
Tittmoning, Bavaria
Country
GERMANYAddress
Gollstr. 1, , Tittmoning, Bavaria, 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
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 |
|---|---|---|---|
| 8/29/2023 | 61PDA66LINAGLIPTIN (ANTI-DIABETIC) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 10/2/2020 | 54FDH20MINT (HERBAL & BOTANICALS, NOT TEAS - IF TEA FORM SEE 31P) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 5/6/2020 | 66VCE99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
Frequently Asked Questions
What is Dragenopharm Apotheker Pueschl GmbH's FDA import refusal history?
Dragenopharm Apotheker Pueschl GmbH (FEI: 3009943598) has 3 FDA import refusal record(s) in our database, spanning from 5/6/2020 to 8/29/2023.
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. Dragenopharm Apotheker Pueschl GmbH's FEI number is 3009943598.
What types of violations has Dragenopharm Apotheker Pueschl GmbH received?
Dragenopharm Apotheker Pueschl 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 Dragenopharm Apotheker Pueschl GmbH come from?
All FDA import refusal data for Dragenopharm Apotheker Pueschl 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.