# FDA 483 - Criticare Technologies, Inc. - October 28, 2025

Source: https://www.globalkeysolutions.net/records/483/criticare-technologies-inc/aab29aa8-866a-4ab6-a2fb-659404609902

> FDA 483 for Criticare Technologies, Inc. on October 28, 2025. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Criticare Technologies, Inc.
- Inspection Date: 2025-10-28
- Product Type: device
- Office Name: New England District Office
- Summary: An FDA inspection of Criticare Technologies, Inc. in Warwick, RI, revealed significant and repeat deficiencies in their quality system for nGenuity and eQuality Vital Signs Monitors. Key issues included inadequate corrective and preventive actions, flawed complaint handling and MDR procedures, insufficient design verification and validation, and a failure to properly assess the impact of out-of-tolerance test equipment. The firm also lacked adequate purchasing controls, documented production processes, and an updated design risk analysis, indicating systemic problems in ensuring device quality and safety.

## Related Documents

- [483 - 2017-03-29](https://www.globalkeysolutions.net/records/483/criticare-technologies-inc/e595c59e-3e8f-47ff-93cb-a8c7c4b055f3)
- [483 - 2018-06-11](https://www.globalkeysolutions.net/records/483/criticare-technologies-inc/16ead53d-78a7-4bc3-bd21-8f34d6947c02)
- [483 - 2024-05-10](https://www.globalkeysolutions.net/records/483/criticare-technologies-inc/98473a7a-3300-4692-a085-fcc116e8b767)
- [WARNING_LETTER - 2024-05-10](https://www.globalkeysolutions.net/records/warning_letter/criticare-technologies-inc/557718dd-64ce-437d-9f13-05cea5aa58ab)

## Related Officers

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

Company: https://www.globalkeysolutions.net/companies/criticare-technologies-inc/f0597e63-c149-46f6-a474-fe9c1c8a951a

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