# FDA 483 - ZiphyCare, Inc. - July 30, 2025

Source: https://www.globalkeysolutions.net/records/483/ziphycare-inc/86a0cedf-f468-4500-ac86-9b1ee9d57794

> FDA 483 for ZiphyCare, Inc. on July 30, 2025. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: ZiphyCare, Inc.
- Inspection Date: 2025-07-30
- Product Type: device
- Office Name: New York District Office
- Summary: An FDA inspection of ZiphyCare, Inc., a medical device manufacturer in New York, revealed significant deficiencies in their quality system. The firm failed to maintain proper Medical Device Reporting procedures, did not submit required device listing information, and lacked proper approval documentation for critical quality system documents.

## Related Documents

- [483 - 2022-09-06](https://www.globalkeysolutions.net/records/483/ziphycare-inc/91fd6e33-1b69-4c36-b39c-84924aaee163)

## Related Officers

- [investigator](https://www.globalkeysolutions.net/people/kwong-p-lee/f4778925-1fad-4988-9e39-86482896c4fa)

Company: https://www.globalkeysolutions.net/companies/ziphycare-inc/67728440-e098-45ca-b2d1-12551fabca84

Office: https://www.globalkeysolutions.net/offices/new-york-district-office/9fa3d265-16ca-438d-8a6e-b47f60dc260d