# FDA 483 - Zyno Medical LLC - February 15, 2022

Source: https://www.globalkeysolutions.net/records/483/zyno-medical-llc/b885e180-d85d-4d11-80d4-639c9f32adcc

> FDA 483 for Zyno Medical LLC on February 15, 2022. Product: device. Access full analysis and detailed observations.

---

## Details

- Record Type: 483
- Company Name: Zyno Medical LLC
- Inspection Date: 2022-02-15
- Product Type: device
- Office Name: FDA District Office — Stoneham, Massachusetts
- Summary: An FDA inspection of Zyno Medical LLC in Natick, MA, a manufacturer of infusion pumps and administration sets, revealed significant deficiencies across its quality system. The firm failed to adequately establish procedures for design changes, control non-conforming products, implement corrective and preventive actions, and properly handle complaints. Additionally, issues were noted in supplier evaluation and timely submission of Medical Device Reports.

## Related Documents

- [WARNING_LETTER - 2022-02-15](https://www.globalkeysolutions.net/records/warning_letter/zyno-medical-llc/de7044c7-7048-49e9-8a9d-9aca14308d4b)
- [483 - 2023-08-16](https://www.globalkeysolutions.net/records/483/zyno-medical-llc/df624153-c470-4f2a-bf0a-e6a8504885ab)
- [483 - 2025-09-18](https://www.globalkeysolutions.net/records/483/zyno-medical-llc/465d5a17-4f0b-47b1-af1f-dbc2133882d3)
- [483 - Unknown Date](https://www.globalkeysolutions.net/records/483/zyno-medical-llc/a330638f-664d-4ead-ad40-24c15aa3d748)

## Related Officers

- [Sara M. Onyango](https://www.globalkeysolutions.net/people/sara-m-onyango/643c6ad3-9747-4bc2-9e8e-72f97b11e659)

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

Office: https://www.globalkeysolutions.net/offices/fda-district-office-stoneham-massachusetts/1daceb4f-4057-46cf-af02-d4ccde44dcc7