# FDA 483 - JAS Diagnostics, Inc./Drew Scientific, Inc. - June 12, 2025

Source: https://www.globalkeysolutions.net/records/483/jas-diagnostics-incdrew-scientific-inc/ac671f89-8714-435a-8785-f37cee039961

> FDA 483 for JAS Diagnostics, Inc./Drew Scientific, Inc. on June 12, 2025. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: JAS Diagnostics, Inc./Drew Scientific, Inc.
- Inspection Date: 2025-06-12
- Product Type: device
- Office Name: Florida District Office
- Summary: JAS Diagnostics, Inc./Drew Scientific, Inc. in Miami Lakes, FL, was inspected and cited for significant quality system deficiencies. Observations included inadequate process validation, failure to maintain complaint files and conduct investigations, and lack of established design control procedures. Additionally, the firm failed to adequately implement supplier controls and did not document personnel training or evaluate its effectiveness, with some employees lacking required training for over a decade.

## Related Documents

- [483 - 2019-08-29](https://www.globalkeysolutions.net/records/483/jas-diagnostics-incdrew-scientific-inc/7159ca57-fcb9-4a5d-bf03-475f5a86ff6d)
- [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)

## Related Officers

- [investigator](https://www.globalkeysolutions.net/people/ronald-ifraimov/b4ce8b79-3fa2-4862-b7a4-68e14e45d87a)

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

Office: https://www.globalkeysolutions.net/offices/florida-district-office/95b2a118-0b78-46e0-a54c-982bd7ce51c9