# FDA 483 - Bernd Richter GmbH - February 16, 2023

Source: https://www.keypedia.com/records/483/bernd-richter-gmbh/50cef077-546c-4c54-a8c2-8286894feab1

> FDA 483 for Bernd Richter GmbH on February 16, 2023. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Bernd Richter GmbH
- Inspection Date: 2023-02-16
- Product Type: drugs
- Office Name: Center for Devices and Radiological Health
- Summary: An FDA inspection of Bernd Richter GmbH in Wipperfurth, Germany, identified significant issues related to process control and in-process product acceptance. The firm failed to provide documentation for the validation of a crimping machine and lacked adequately established procedures for in-process testing. These findings indicate deficiencies in the firm's quality system regarding manufacturing process control and product quality assurance.

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Company: https://www.keypedia.com/companies/bernd-richter-gmbh/412d5fc6-4581-420a-9bd5-3f99b9a8e273

Office: https://www.keypedia.com/offices/center-for-devices-and-radiological-health/9d89aff6-e435-4764-87be-f58c01aca7f7