# FDA 483 - Merete GmbH - August 29, 2018

Source: https://www.keypedia.com/records/483/merete-gmbh/5a4aa32a-3c72-45b4-86e3-ddce4af98501

> FDA 483 for Merete GmbH on August 29, 2018. Product: devices. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Merete GmbH
- Inspection Date: 2018-08-29
- Product Type: devices
- Office Name: Office of Regulatory Affairs
- Summary: An FDA inspection conducted from August 27-29, 2018, at Merete Medical GmbH in Berlin, Germany, identified significant deficiencies in the firm's quality system for medical devices. The inspection, resulting in a Form FDA-483, highlighted seven main observations. Key issues included a failure to submit seven Medical Device Report (MDR) reports within the required 30-day timeframe for events related to their BioBall system and post-operation infections. The firm also lacked established procedures for corrective and preventive actions, evident in inadequate investigations of recurring BioBall system complaints. Significant problems were noted in design control, with the Intrablock BioBall Hip System not undergoing proper design validation under actual or simulated use conditions, and design verification failing to confirm that design output met input requirements prior to U.S. commercialization. Furthermore, procedures for receiving, reviewing, and evaluating complaints were not established, leading to deficient complaint records and inadequate complaint handling. Design input requirements for the Intrablock BioBall Hip System and its instruments were also not adequately documented, including shelf-life and transportation conditions. Finally, the firm had not developed or implemented written MDR procedures. Merete Medical GmbH acknowledged these observations, promising to implement corrective actions for each identified deficiency, as is required under the Federal Food, Drug, and Cosmetic Act to ensure compliance with quality system regulations for medical devices.

## Related Documents

- [483 - 2018-08-29](https://www.keypedia.com/records/483/merete-gmbh/ce1f9f8d-a6ed-442b-9e6c-862c995a8898)

## Related Officers

- [Ashley A. Mutawakkil](https://www.keypedia.com/people/ashley-a-mutawakkil/512be391-fd96-451c-9569-98e43cfba9db)

Company: https://www.keypedia.com/companies/merete-gmbh/756e1255-3cc0-4585-8a62-bb869e1e9b8b

Office: https://www.keypedia.com/offices/office-of-regulatory-affairs/ff91c598-cf72-4dbe-a2c8-7519c64cbc64