# FDA 483 - PAJUNK GMBH MEDIZINTECHNOLOGIE - February 06, 2025

Source: https://www.keypedia.com/records/483/pajunk-gmbh-medizintechnologie/aeea9908-f145-4f9d-a03a-d4d54120cb74

> FDA 483 for PAJUNK GMBH MEDIZINTECHNOLOGIE on February 06, 2025. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: PAJUNK GMBH MEDIZINTECHNOLOGIE
- Inspection Date: 2025-02-06
- Product Type: device
- Office Name: Office of Medical Device and Radiological Health Operations
- Summary: PAJUNK GMBH MEDIZINTECHNOLOGIE, a medical device manufacturer in Geisingen, Germany, was cited for three observations during an FDA inspection. The firm's procedures for corrective and preventive actions, labeling control, and complaint handling were found to be inadequately established. These deficiencies indicate a lack of robust quality system controls, particularly concerning root cause analysis, label integrity, and the evaluation and reporting of potential Medical Device Reports.

## Related Officers

- [issuing_officer](https://www.keypedia.com/people/maryam-tabatabaie/b792042d-e296-446d-90a9-d30c8f635506)

Company: https://www.keypedia.com/companies/pajunk-gmbh-medizintechnologie/906e4e1a-b57a-4160-a144-d6352d0ec0f3

Office: https://www.keypedia.com/offices/office-of-medical-device-and-radiological-health-operations/27658190-735a-443e-9087-3534cfe74fd4