# FDA 483 - ZIIP INC - January 12, 2026

Source: https://www.keypedia.com/records/483/ziip-inc/271b8083-f3b3-47ac-9fb0-0ea892dfa12d

> FDA 483 for ZIIP INC on January 12, 2026. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: ZIIP INC
- Inspection Date: 2026-01-12
- Product Type: device
- Office Name: New England District Office
- Summary: ZIIP INC, a manufacturer of the ZIIP HALO device in Pleasant Hill, CA, was cited for significant deficiencies in its quality system during an FDA inspection. Observations included inadequate complaint handling, ineffective corrective and preventive actions, and failures in design control processes, including verification, validation, and change management. The firm also failed to adequately assess risks, submit required MDRs for serious malfunctions, and maintain a device master record.

## Related Documents

- [WARNING_LETTER - 2026-01-12](https://www.keypedia.com/records/warning_letter/ziip-inc/ef546c17-3a9d-4d3b-872f-714a8148729a)

## Related Officers

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

Company: https://www.keypedia.com/companies/ziip-inc/5af903bf-68b4-49c3-a028-9b47eb62c139

Office: https://www.keypedia.com/offices/new-england-district-office/aa458072-2f1d-4231-89f5-21ba7a3b7144