# FDA 483 - Berlin Heart Inc - July 02, 2025

Source: https://www.keypedia.com/records/483/berlin-heart-inc/054b2d8f-c79e-47db-b5dd-6184f7820f55

> FDA 483 for Berlin Heart Inc on July 02, 2025. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Berlin Heart Inc
- Inspection Date: 2025-07-02
- Product Type: device
- Office Name: Dallas District Office
- Summary: Berlin Heart Inc, a servicer of the EXCOR Pediatric Ventricular Assist Device (VAD), was inspected and received two observations. The inspection revealed inadequate procedures for servicing activities, including failures in documenting service reports, evaluating MDR reportability, and using statistical methodology. Additionally, the firm's quality system software, including Excel spreadsheets and fillable PDFs used for critical records, was not validated for its intended use, leading to issues with document control and data integrity.

## Related Documents

- [483 - 2025-07-02](https://www.keypedia.com/records/483/berlin-heart-inc/f6552a31-9ccb-481e-95a7-ce5b01b98dfe)

## Related Officers

- [Jocelyn C. Turner](https://www.keypedia.com/people/jocelyn-c-turner/7e39f6e0-9750-4460-8a4e-27ee9306b77e)

Company: https://www.keypedia.com/companies/berlin-heart-inc/770841f7-c04e-4185-8655-d4c21aa03751

Office: https://www.keypedia.com/offices/dallas-district-office/2d1ee9ae-c44c-4494-8186-a920a69b98f9