ImportRefusal LogoImportRefusal

ITM Medical Isotopes GmbH

⚠️ Moderate Risk

FEI: 3010531211 • Garching B. Munchen, Bavaria • GERMANY

FEI

FEI Number

3010531211

📍

Location

Garching B. Munchen, Bavaria

🇩🇪

Country

GERMANY
🏢

Address

Iaz Bldg (And Am Gfild 2 & 11 Neufahrn Bei Freising 85375, Lichtenbergstr. 1, Garching B. Munchen, Bavaria, Germany

Moderate Risk

FDA Import Risk Assessment

41.8
LowModerateHighCritical

This firm has a moderate history of FDA import refusals. Some attention may be warranted.

Statistics

4
Total Refusals
2
Unique Violations
9/22/2020
Latest Refusal
10/18/2018
Earliest Refusal

Score Breakdown

Violation Severity
80.0×40%
Refusal Volume
25.9×30%
Recency
0.0×20%
Frequency
20.7×10%
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

© ImportRefusal.com Original Analysis

Violation Summary

753×

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).

32801×

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.

Refusal History

DateProductViolationsDivision
9/22/2020
65NIY99RADIOACTIVE AGENT N.E.C.
75UNAPPROVED
Division of Southwest Imports (DSWI)
10/18/2018
65NIY99RADIOACTIVE AGENT N.E.C.
3280FRNMFGREG
Division of Southwest Imports (DSWI)
10/18/2018
65NIY99RADIOACTIVE AGENT N.E.C.
75UNAPPROVED
Division of Southwest Imports (DSWI)
10/18/2018
65BIY99MUCOLYTIC N.E.C.
75UNAPPROVED
Division of Southwest Imports (DSWI)

Frequently Asked Questions

What is ITM Medical Isotopes GmbH's FDA import refusal history?

ITM Medical Isotopes GmbH (FEI: 3010531211) has 4 FDA import refusal record(s) in our database, spanning from 10/18/2018 to 9/22/2020.

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. ITM Medical Isotopes GmbH's FEI number is 3010531211.

What types of violations has ITM Medical Isotopes GmbH received?

ITM Medical Isotopes GmbH 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 ITM Medical Isotopes GmbH come from?

All FDA import refusal data for ITM Medical Isotopes 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.