# FDA 483 - JAS Diagnostics, Inc./Drew Scientific, Inc. - April 28, 2022

Source: https://www.keypedia.com/records/483/jas-diagnostics-incdrew-scientific-inc/8d9c4392-799d-44d7-a27e-a101690f9238

> FDA 483 for JAS Diagnostics, Inc./Drew Scientific, Inc. on April 28, 2022. 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: 2022-04-28
- Product Type: device
- Office Name: Office of Medical Device and Radiological Health Division II
- Summary: JAS Diagnostics, Inc./Drew Scientific, Inc. in Miami Lakes, FL, was cited for numerous deficiencies across its quality system during an FDA inspection. Key issues include inadequate complaint handling, ineffective corrective and preventive actions, and a lack of proper process and design validations for its medical devices and reagents. The inspection revealed systemic failures in quality control, supplier management, and employee training, many of which are repeat observations from previous inspections and an Untitled Letter.

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- [WARNING_LETTER - 2022-04-28](https://www.keypedia.com/records/warning_letter/jas-diagnostics-incdrew-scientific-inc/7396c4f4-9fee-40b5-a912-d665a354ffb6)
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## Related Officers

- [Alex J. Wild](https://www.keypedia.com/people/alex-j-wild/bb1b66b3-19b9-480e-af0b-f06f8de0d930)
- [investigator](https://www.keypedia.com/people/karen-m-rodriguez/fcef1f49-583d-45ab-80e2-4c34793fd722)

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

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