Source: FDA inspection record. Confirmed against FDA's published inspection data for this establishment and inspection date. FDA has published the inspection and what it cited, but not the form itself, which usually takes six to twelve months. To check it, open FDA's record for this establishment on FDA's Data Dashboard, listed under FEI 3003071743.
Observations5
Issue DateJune 12, 2025
Status1 Related Warning Letter
Related Inspections6
Establishment Details
Firm
JAS Diagnostics, Inc./Drew Scientific, Inc.
Location
Miami Lakes, Florida, United States
FEI Number
3003071743
Product Type
Devices
Issue Date
June 12, 2025
Country
United States
Inspection History, 2009 to 2025
VAI4
OAI2
VAI means Voluntary Action Indicated. OAI means Official Action Indicated.