# FDA 483 - BERLIN HEART GMBH - October 13, 2022

Source: https://www.globalkeysolutions.net/records/483/berlin-heart-gmbh/2c52abc5-ddfb-4697-9b42-cb71ef817d72

> FDA 483 for BERLIN HEART GMBH on October 13, 2022. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: BERLIN HEART GMBH
- Inspection Date: 2022-10-13
- Product Type: device
- Office Name: Division of Clinical Evidence and Analysis 1 (Clinical Policy and Quality)
- Summary: BERLIN HEART GMBH, a medical device manufacturer in Berlin, Germany, was cited for multiple quality system deficiencies during an FDA inspection. Observations included inadequate corrective and preventive action procedures, a lack of standardized medical device reporting processes, and deficiencies in design control procedures for both input and output. Additionally, the firm failed to ensure device history records aligned with master records and did not report a significant correction or removal to the FDA.

## Related Documents

- [483 - 2022-10-13](https://www.globalkeysolutions.net/records/483/berlin-heart-gmbh/3693453e-89d7-4fcf-a05a-8ef8f5834d22)

## Related Officers

- [Joshua J. Silvestri](https://www.globalkeysolutions.net/people/joshua-j-silvestri/433e29b3-ce5f-44d2-9984-7a6cb61e1824)

Company: https://www.globalkeysolutions.net/companies/berlin-heart-gmbh/91a114a5-6d49-4328-95a6-cb5d05a4bdeb

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