# FDA 483 - Rapid Biomedical GmbH - July 05, 2018

Source: https://www.keypedia.com/records/483/rapid-biomedical-gmbh/4983fea7-1b5c-49a8-bf6f-992e0248c4a7

> FDA 483 for Rapid Biomedical GmbH on July 05, 2018. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Rapid Biomedical GmbH
- Inspection Date: 2018-07-05
- Product Type: device
- Office Name: Division of Clinical Evidence and Analysis 1 (Clinical Policy and Quality)
- Summary: Raumedical GmbH, a medical device manufacturer in Rimpar, Germany, was cited for significant quality system deficiencies during an FDA inspection. The firm's medical device reporting procedures were found to be inadequate, and software used in production and the quality system was not validated. Additionally, sampling plans lacked statistical rationale, and corrective and preventive action procedures were not adequately established.

## Related Documents

- [483 - 2018-07-02](https://www.keypedia.com/records/483/rapid-biomedical-gmbh/a98db2ab-649a-4779-95bf-b2fc8a389202)

## Related Officers

- [issuing_officer](https://www.keypedia.com/people/roy-baby/69a18ef5-167c-41eb-a57e-3d138a0820c2)

Company: https://www.keypedia.com/companies/rapid-biomedical-gmbh/bc5e2664-41f4-44b4-bede-d9f532b6cc38

Office: https://www.keypedia.com/offices/division-of-clinical-evidence-and-analysis-1-clinical-policy-and-quality/5f95da17-30bb-423f-b892-5ea041823fbd