# FDA 483 - ZiphyCare, Inc. - September 06, 2022

Source: https://www.globalkeysolutions.net/records/483/ziphycare-inc/91fd6e33-1b69-4c36-b39c-84924aaee163

> FDA 483 for ZiphyCare, Inc. on September 06, 2022. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: ZiphyCare, Inc.
- Inspection Date: 2022-09-06
- Product Type: device
- Office Name: Division of Human and Animal Food Operations - East I
- Summary: An FDA inspection of ZiphyCare, Inc. in New York, NY, a specification developer, revealed significant deficiencies in their quality system. The firm failed to establish adequate procedures for supplier evaluation, design changes, document control, and software validation. These issues indicate a broad lack of control over their medical device development and manufacturing processes.

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## Related Officers

- [Colin E. Tack](https://www.globalkeysolutions.net/people/colin-e-tack/5bdbf977-d4ac-48fe-81cc-ada89379ed0d)

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

Office: https://www.globalkeysolutions.net/offices/division-of-human-and-animal-food-operations-east-i/a807f00e-d780-40b8-b233-1eb92ece8961