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

Source: https://www.globalkeysolutions.net/records/483/itm-medical-isotopes-gmbh/37fd78c0-13b2-4262-a395-6299f05a4026

> FDA 483 for ITM Medical Isotopes GmbH on January 14, 2022. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: ITM Medical Isotopes GmbH
- Inspection Date: 2022-01-14
- Product Type: drugs
- Office Name: Office of Biological Products Operations - Division I
- Summary: 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.

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- [Investigator](https://www.globalkeysolutions.net/people/kham-phommachanh/cc7e728e-d2a1-469d-be3a-4f5fdd43b2dc)

Company: https://www.globalkeysolutions.net/companies/itm-medical-isotopes-gmbh/7b570afa-7e97-4ceb-9304-5b7f4492eb4e

Office: https://www.globalkeysolutions.net/offices/office-of-biological-products-operations-division-i/49c53dac-7724-4c8c-8708-4f5779ea69c1