Mr. Jean Felix LaCroix
Owner/CEO
JAS Diagnostics/Drew Scientific, Inc.
14100 NW 57th Ct
Miami Lakes , FL 33014-3107
United States
Flacroix@JASdrew.comFEI 3003071743Issued Aug 16, 2022Center for Devices and Radiological Health
Source: FDA, published letter. FDA published this warning letter; View Letter opens FDA's copy. To check it, open FDA's record for this establishment, listed under FEI 3003071743.
Violations5
Issue DateAug 16, 2022
Product TypeMedical Devices
StatusOpen
Letter Details
Firm
JAS Diagnostics/Drew Scientific, Inc.
Location
Mr. Jean Felix LaCroix
Owner/CEO
JAS Diagnostics/Drew Scientific, Inc.
14100 NW 57th Ct
Miami Lakes , FL 33014-3107
United States
Flacroix@JASdrew.com
FEI Number
3003071743
Country
United States
Issue Date
August 16, 2022
Issuing Office
Center for Devices and Radiological Health
Product Type
Medical Devices
Status
Open
Summary
JAS Diagnostics/Drew Scientific, Inc., a manufacturer and repackager of in vitro diagnostic chemistry and hematology reagents, failed to comply with current good manufacturing practice requirements under 21 CFR Part 820. During an April 2022 inspection, the FDA identified critical quality system violations, including failure to adequately establish and implement complaint handling procedures to document, investigate, and evaluate complaints for Medical Device Reportable (MDR) events. The company's devices were determined to be adulterated due to non-conformity of manufacturing methods, facilities, and controls with FDA quality system regulations.
JAS Diagnostics/Drew Scientific, Inc. FDA Warning Letter, August 16, 2022
Talk to a Specialist