Paul Hartmann AG
⚠️ Moderate Risk
FEI: 2926 • Heidenheim An Der Brenz • GERMANY
FEI Number
2926
Location
Heidenheim An Der Brenz
Country
GERMANYAddress
Paul Hartmann Strasse, , Heidenheim An Der Brenz, , 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).
REGISTERED
It appears the device is subject to listing under 510(j) and the initial distributor has not registered as required by 21 CFR 807.20 (a)(5).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 6/11/2008 | 79LRRKIT, FIRST AID | 341REGISTERED | Los Angeles District Office (LOS-DO) |
| 8/28/2002 | 79LRRKIT, FIRST AID | Chicago District Office (CHI-DO) | |
| 1/3/2002 | 79LRRKIT, FIRST AID | 118NOT LISTED | Chicago District Office (CHI-DO) |
| 1/3/2002 | 79LRRKIT, FIRST AID | 118NOT LISTED | Chicago District Office (CHI-DO) |
Frequently Asked Questions
What is Paul Hartmann AG's FDA import refusal history?
Paul Hartmann AG (FEI: 2926) has 4 FDA import refusal record(s) in our database, spanning from 1/3/2002 to 6/11/2008.
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. Paul Hartmann AG's FEI number is 2926.
What types of violations has Paul Hartmann AG received?
Paul Hartmann AG has been cited for 2 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 Paul Hartmann AG come from?
All FDA import refusal data for Paul Hartmann AG 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.