Omega Medical Imaging, Inc.

Form 483

Sanford, Florida, United StatesFEI 1000222289Issued February 24, 2017

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 1000222289.

Observations5

Issue DateFebruary 24, 2017

StatusNo Warning Letter

Related Inspections7

Establishment Details

Firm: Omega Medical Imaging, Inc.
Location: Sanford, Florida, United States
FEI Number: 1000222289
Product Type: Devices
Issue Date: February 24, 2017
Country: United States

Inspection History, 2009 to 2025

NAI1

VAI6

NAI means No Action Indicated. VAI means Voluntary 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.

Omega Medical Imaging, Inc. FDA Form 483, Sanford, Florida, February 24, 2017