# FDA 483 - Flexicare Medical Ltd. - August 02, 2018

Source: https://www.globalkeysolutions.net/records/483/flexicare-medical-ltd/7363a472-68b7-4592-890b-06e892665978

> FDA 483 for Flexicare Medical Ltd. on August 02, 2018. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Flexicare Medical Ltd.
- Inspection Date: 2018-08-02
- Product Type: device
- Office Name: International Compliance Team
- Summary: An FDA inspection of Flexicare Medical Ltd., a medical device manufacturer in Rhondda Cynon Taff, UK, revealed significant deficiencies in their quality system. The firm failed to submit Medical Device Reports (MDRs) in a timely manner, lacked adequate procedures for Corrective and Preventive Actions (CAPA), and exhibited issues with design transfer and design validation for their Infiant CPAP device. Additionally, complaint investigations were found to be inadequate, failing to fully assess the significance of device failures.

## Related Officers

- [investigator](https://www.globalkeysolutions.net/people/stephen-d-eich/a932e816-cbe3-4f1c-84e7-8a81cc8b529e)

Company: https://www.globalkeysolutions.net/companies/flexicare-medical-ltd/caa36dfe-2042-4376-b1d8-0044847f2842

Office: https://www.globalkeysolutions.net/offices/international-compliance-team/f0ce0d89-bf39-46c6-8c42-28138d161321