# FDA 483 - Zyno Medical LLC - August 16, 2023

Source: https://www.keypedia.com/records/483/zyno-medical-llc/df624153-c470-4f2a-bf0a-e6a8504885ab

> FDA 483 for Zyno Medical LLC on August 16, 2023. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Zyno Medical LLC
- Inspection Date: 2023-08-16
- Product Type: device
- Office Name: Division of Northeast Imports 
- Summary: Zyno Medical LLC, a manufacturer of infusion pumps in Natick, MA, was cited with four observations during an FDA inspection. The firm failed to adequately establish CAPA procedures, investigate complaints in a timely manner, and submit Medical Device Reports within the required timeframe. Additionally, management did not review the quality system at defined intervals, indicating significant deficiencies in their quality management system.

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## Related Officers

- [Nabil Nakhoul](https://www.keypedia.com/people/nabil-nakhoul/d676e9c9-566c-4e59-84e8-1dc474e4e48d)

Company: https://www.keypedia.com/companies/zyno-medical-llc/d35883d0-5ef2-4a3b-8613-178bd16faec4

Office: https://www.keypedia.com/offices/division-of-northeast-imports/b20599cf-9797-41fd-947f-6589ef596a94