ITM Medical Isotopes GmbHJanuary 14, 2022

FDA 483 - ITM Medical Isotopes GmbH - January 14, 2022

View on Dashboard

Discuss this record with AI

ChatGPT

Claude

Perplexity

Grok

Copilot

Document or profile

One record shows the event. A profile shows the pattern.

Buy this document for the source file and details behind this single event.

Choose full profile access to connect related records, sites, people, citations, and enforcement history in one view.

Explore ITM Medical Isotopes GmbH

Record Details

An FDA inspection of ITM Medical Isotopes GmbH, an API drug manufacturer in Garching B. Munchen, Bavaria, revealed significant deficiencies in quality system controls. Observations included incomplete training records, non-contemporaneous batch records, inadequate computer system security, and unclosed change controls. These issues indicate a need for improved documentation practices and data integrity.

Company: ITM Medical Isotopes GmbH
Inspection Date: January 14, 2022
Product Type: Drugs
Office: Office of Biological Products Operations - Division I
Person: Kham Phommachanh (Investigator)

Open in Dashboard

ID · 37fd78c0-13b2-4262-a395-6299f05a4026