# FDA 483 - Medical Accessories and Cables LLC - August 26, 2019

Source: https://www.globalkeysolutions.net/records/483/medical-accessories-and-cables-llc/be0e1a24-c56d-4a7a-802e-2ec9c5420f91

> FDA 483 for Medical Accessories and Cables LLC on August 26, 2019. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Medical Accessories and Cables LLC
- Inspection Date: 2019-08-26
- Product Type: device
- Office Name: Dallas District Office
- Summary: Medical Accessories and Cables LLC, a specification developer of medical device cables in Houston, TX, was cited for significant deficiencies during an FDA inspection. The firm failed to establish procedures for receiving, reviewing, and evaluating complaints, leading to undocumented investigations of defective devices. Additionally, the company lacked developed, maintained, and implemented written Medical Device Reporting (MDR) procedures, failing to ensure timely and accurate reporting of adverse events.

## Related Officers

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

Company: https://www.globalkeysolutions.net/companies/medical-accessories-and-cables-llc/919e944b-e064-4be8-9e0d-fc530a2a251c

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