# FDA 483 - Miltenyi Biotec Gmbh - May 29, 2015

Source: https://www.keypedia.com/records/483/miltenyi-biotec-gmbh/4b49f924-ab4e-4d0c-b5a0-17b81f973a5f

> FDA 483 for Miltenyi Biotec Gmbh on May 29, 2015. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Miltenyi Biotec Gmbh
- Inspection Date: 2015-05-29
- Product Type: device
- Office Name: Office of Medical Device and Radiological Health Operations
- Summary: An FDA inspection of Miltenyi Biotec Gmbh in Bergisch Gladbach, Germany, revealed significant deficiencies in their medical device reporting and complaint handling procedures. The firm failed to establish adequate systems for identifying reportable events, documenting complaints, and maintaining complete investigation records. These findings indicate a need for comprehensive corrective actions to ensure compliance with regulatory requirements.

## Related Officers

- [Cynthia T. Cain](https://www.keypedia.com/people/cynthia-t-cain/8b1dcf2b-198c-4218-8cd5-458f62718c1f)

Company: https://www.keypedia.com/companies/miltenyi-biotec-gmbh/4601c118-fc51-4c77-beed-8d65b6d09c7a

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