LTS Lohmann Therapie-Systeme AG

⚠️ High Risk

FEI: 3003387535 • Andernach, Rhineland-Palatinate • GERMANY

FEI

FEI Number

3003387535

📍

Location

Andernach, Rhineland-Palatinate

🇩🇪

Country

GERMANY

🏢

Address

Lohmannstr. 2, , Andernach, Rhineland-Palatinate, Germany

High Risk

FDA Import Risk Assessment

54.3

LowModerateHighCritical

This firm has a significant history of FDA import refusals with notable violations.

Statistics

Total Refusals

Unique Violations

1/7/2025

Latest Refusal

10/19/2005

Earliest Refusal

Score Breakdown

Violation Severity

78.9×40%

Refusal Volume

31.3×30%

Recency

65.4×20%

Frequency

3.1×10%

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

Violation Summary

756×

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).

162×

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.

3411×

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
1/7/2025	64GCY19ETHINYL ESTRADIOL (ESTROGEN)	75UNAPPROVED	Division of Southeast Imports (DSEI)
9/20/2013	66BAY44NICOTINE DELIVERY SYSTEM	75UNAPPROVED	New York District Office (NYK-DO)
1/17/2012	66YIY99EXHIBITS - OTHER DRUG RELATED ITEMS N.E.C.	16DIRECTIONS 75UNAPPROVED	New York District Office (NYK-DO)
1/17/2012	66YIY99EXHIBITS - OTHER DRUG RELATED ITEMS N.E.C.	16DIRECTIONS 75UNAPPROVED	New York District Office (NYK-DO)
4/9/2009	66VDY99MISCELLANEOUS PATENT MEDICINES, ETC.	75UNAPPROVED	New York District Office (NYK-DO)
10/19/2005	85LLQCAP, CERVICAL, CONTRACEPTIVE	341REGISTERED 75UNAPPROVED	Florida District Office (FLA-DO)

Frequently Asked Questions

What is LTS Lohmann Therapie-Systeme AG's FDA import refusal history?

LTS Lohmann Therapie-Systeme AG (FEI: 3003387535) has 6 FDA import refusal record(s) in our database, spanning from 10/19/2005 to 1/7/2025.

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. LTS Lohmann Therapie-Systeme AG's FEI number is 3003387535.

What types of violations has LTS Lohmann Therapie-Systeme AG received?

LTS Lohmann Therapie-Systeme AG 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 LTS Lohmann Therapie-Systeme AG come from?

All FDA import refusal data for LTS Lohmann Therapie-Systeme 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.