Paritec Gmbh
⚠️ High Risk
FEI: 3003052822 • Weilheim i. OB, Bavaria • GERMANY
FEI Number
3003052822
Location
Weilheim i. OB, Bavaria
Country
GERMANYAddress
Holzhofstr. 10b, , Weilheim i. OB, 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
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).
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 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.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 11/13/2025 | 73CAFNEBULIZER (DIRECT PATIENT INTERFACE) | Division of Southwest Imports (DSWI) | |
| 11/13/2025 | 73CAFNEBULIZER (DIRECT PATIENT INTERFACE) | Division of Southwest Imports (DSWI) | |
| 11/13/2025 | 73CAFNEBULIZER (DIRECT PATIENT INTERFACE) | Division of Southwest Imports (DSWI) | |
| 11/13/2025 | 73CAFNEBULIZER (DIRECT PATIENT INTERFACE) | Division of Southwest Imports (DSWI) | |
| 11/13/2025 | 73CAFNEBULIZER (DIRECT PATIENT INTERFACE) | Division of Southwest Imports (DSWI) | |
| 11/13/2025 | 73CAFNEBULIZER (DIRECT PATIENT INTERFACE) | Division of Southwest Imports (DSWI) | |
| 11/13/2025 | 73CAFNEBULIZER (DIRECT PATIENT INTERFACE) | Division of Southwest Imports (DSWI) |
Frequently Asked Questions
What is Paritec Gmbh's FDA import refusal history?
Paritec Gmbh (FEI: 3003052822) has 7 FDA import refusal record(s) in our database, spanning from 11/13/2025 to 11/13/2025.
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. Paritec Gmbh's FEI number is 3003052822.
What types of violations has Paritec Gmbh received?
Paritec Gmbh 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 Paritec Gmbh come from?
All FDA import refusal data for Paritec 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.