# FDA 483 - Phoenix Diagnostics, Inc. - March 17, 2022

Source: https://www.globalkeysolutions.net/records/483/phoenix-diagnostics-inc/93e2af9e-e533-4618-83f9-f8a0915518f7

> FDA 483 for Phoenix Diagnostics, Inc. on March 17, 2022. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Phoenix Diagnostics, Inc.
- Inspection Date: 2022-03-17
- Product Type: device
- Office Name: FDA District Office — Stoneham, Massachusetts
- Summary: Phoenix Diagnostics, Inc. in Natick, MA, received a Form FDA 483 with four observations following an inspection. The firm demonstrated inadequate procedures for corrective and preventive actions, employee training, control of nonconforming materials, and quality audits. One observation regarding training was a repeat finding, indicating persistent issues with their quality system.

## Related Officers

- [investigator](https://www.globalkeysolutions.net/people/james-p-finn/70e5c36c-2711-449b-bf73-e08b4dd58449)

Company: https://www.globalkeysolutions.net/companies/phoenix-diagnostics-inc/e6758401-487c-47a5-8942-ac7f5e87b05a

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