483
Bernd Richter GmbHFDA 483 - Bernd Richter GmbH - February 16, 2023
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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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ID · 50cef077-546c-4c54-a8c2-8286894feab1