Dr. Paul Lohmann GmbH KG
⚠️ Moderate Risk
FEI: 3004273201 • Emmerthal, Lower Saxony • GERMANY
FEI Number
3004273201
Location
Emmerthal, Lower Saxony
Country
GERMANYAddress
Hauptstr. 2, , Emmerthal, Lower 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
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).
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 |
|---|---|---|---|
| 11/25/2013 | 66VIT99MISCELLANEOUS PATENT MEDICINES, ETC. | 118NOT LISTED | New Orleans District Office (NOL-DO) |
| 11/12/2013 | 45XG99PH CONTROL AGENTS (FOOD ADDITIVES FOR HUMAN USE) | 75UNAPPROVED | San Juan District Office (SJN-DO) |
| 8/12/2013 | 65CCR03POTASSIUM ASPARTATE AND MAGNESIUM ASPARTATE (NUTRIENT/TONIC) | New York District Office (NYK-DO) | |
| 8/12/2013 | 65CCR03POTASSIUM ASPARTATE AND MAGNESIUM ASPARTATE (NUTRIENT/TONIC) | New York District Office (NYK-DO) |
Frequently Asked Questions
What is Dr. Paul Lohmann GmbH KG's FDA import refusal history?
Dr. Paul Lohmann GmbH KG (FEI: 3004273201) has 4 FDA import refusal record(s) in our database, spanning from 8/12/2013 to 11/25/2013.
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. Dr. Paul Lohmann GmbH KG's FEI number is 3004273201.
What types of violations has Dr. Paul Lohmann GmbH KG received?
Dr. Paul Lohmann GmbH 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 Dr. Paul Lohmann GmbH KG come from?
All FDA import refusal data for Dr. Paul Lohmann GmbH 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.