# FDA 483 - Zyno Medical LLC - September 18, 2025

Source: https://www.keypedia.com/records/483/zyno-medical-llc/465d5a17-4f0b-47b1-af1f-dbc2133882d3

> FDA 483 for Zyno Medical LLC on September 18, 2025. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Zyno Medical LLC
- Inspection Date: 2025-09-18
- Product Type: device
- Office Name: New England District Office
- Summary: Zyno Medical LLC, a medical device manufacturer in Natick, MA, received a Form FDA 483 with one repeat observation. The firm failed to submit 60 Medical Device Reports (MDRs) within the required 30-day timeframe, indicating a significant issue with their reporting procedures for device malfunctions. This is a repeat observation, highlighting a persistent compliance problem.

## Related Documents

- [483 - 2022-02-15](https://www.keypedia.com/records/483/zyno-medical-llc/b885e180-d85d-4d11-80d4-639c9f32adcc)
- [WARNING_LETTER - 2022-02-15](https://www.keypedia.com/records/warning_letter/zyno-medical-llc/de7044c7-7048-49e9-8a9d-9aca14308d4b)
- [483 - 2023-08-16](https://www.keypedia.com/records/483/zyno-medical-llc/df624153-c470-4f2a-bf0a-e6a8504885ab)
- [483 - Unknown Date](https://www.keypedia.com/records/483/zyno-medical-llc/a330638f-664d-4ead-ad40-24c15aa3d748)

## 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/new-england-district-office/aa458072-2f1d-4231-89f5-21ba7a3b7144