JAS Diagnostics, Inc./Drew Scientific, Inc.

Form 483FOIA Uncovered

Miami Lakes, Florida, United StatesFEI 3003071743Issued April 28, 2022

View FDA's Record for This Firm

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.

Observations9

Issue DateApril 28, 2022

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: April 28, 2022
Country: United States

Inspection History, 2009 to 2025

VAI4

OAI2

VAI means Voluntary Action Indicated. OAI means Official Action Indicated.

Act on This Form 483

FDA Inspection ReadinessSee how your operations would hold up to the same scrutiny.CAPA & InvestigationsScore how you would investigate and close findings like these.Talk to a SpecialistWalk through these observations with a ComplianceQuest expert.

JAS Diagnostics, Inc./Drew Scientific, Inc. FDA Form 483, Miami Lakes, Florida, April 28, 2022