# FDA 483 - JAS Diagnostics, Inc./Drew Scientific, Inc. - August 29, 2019

Source: https://www.globalkeysolutions.net/records/483/jas-diagnostics-incdrew-scientific-inc/7159ca57-fcb9-4a5d-bf03-475f5a86ff6d

> FDA 483 for JAS Diagnostics, Inc./Drew Scientific, Inc. on August 29, 2019. Product: device. Access full analysis and detailed observations.

---

## Details

- Record Type: 483
- Company Name: JAS Diagnostics, Inc./Drew Scientific, Inc.
- Inspection Date: 2019-08-29
- Product Type: device
- Office Name: Office of Medical Device and Radiological Health Division II
- Summary: JAS Diagnostics/Drew Scientific, Inc./Diamedix Corp. in Miami Lakes, FL, was inspected and cited for significant deficiencies across its quality system for medical devices. The inspection revealed inadequate organizational structure, incomplete corrective and preventive actions, missing design history files, and insufficient risk analysis and process validation. Several observations were repeats from previous inspections, indicating a persistent lack of compliance.

## Related Documents

- [483 - 2022-04-28](https://www.globalkeysolutions.net/records/483/jas-diagnostics-incdrew-scientific-inc/8d9c4392-799d-44d7-a27e-a101690f9238)
- [WARNING_LETTER - 2022-04-28](https://www.globalkeysolutions.net/records/warning_letter/jas-diagnostics-incdrew-scientific-inc/7396c4f4-9fee-40b5-a912-d665a354ffb6)
- [483 - 2025-06-12](https://www.globalkeysolutions.net/records/483/jas-diagnostics-incdrew-scientific-inc/ac671f89-8714-435a-8785-f37cee039961)

## Related Officers

- [Dianiris C. Ayala](https://www.globalkeysolutions.net/people/dianiris-c-ayala/ba6c5538-201b-4c9a-8f23-e160db6868e6)

Company: https://www.globalkeysolutions.net/companies/jas-diagnostics-incdrew-scientific-inc/d2eb6b29-2c6c-486f-9c40-df9fd8995ce4

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