# FDA 483 - The Pyure Company Inc - January 20, 2023

Source: https://www.globalkeysolutions.net/records/483/the-pyure-company-inc/3acd765a-037d-40b2-aa64-01f5dc85b5c9

> FDA 483 for The Pyure Company Inc on January 20, 2023. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: The Pyure Company Inc
- Inspection Date: 2023-01-20
- Product Type: device
- Office Name: Office of Medical Device and Radiological Health Division II
- Summary: The FDA inspected The Pyure Company Inc in Boynton Beach, FL, a manufacturer of the MDU/Rx Air Purifier. The inspection revealed significant deficiencies in design control, including undocumented design input requirements and inadequate design transfer procedures. Additionally, the firm failed to properly evaluate and select critical component suppliers, indicating a moderate level of non-compliance with quality system regulations.

## Related Officers

- [Ashley A. Mutawakkil](https://www.globalkeysolutions.net/people/ashley-a-mutawakkil/512be391-fd96-451c-9569-98e43cfba9db)

Company: https://www.globalkeysolutions.net/companies/the-pyure-company-inc/7792a6f1-a1ff-4b8d-9081-bfa2b4f18046

Office: https://www.globalkeysolutions.net/offices/office-of-medical-device-and-radiological-health-division-ii/ae9bd439-479a-420d-9dd8-9fe1fc0863d6