Kentec Medical, Inc

Form 483

Irvine, California, United StatesFEI 2080225Issued December 16, 2009

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 2080225.

Observations1

Issue DateDecember 16, 2009

StatusNo Warning Letter

Related Inspections5

Establishment Details

Firm: Kentec Medical, Inc
Location: Irvine, California, United States
FEI Number: 2080225
Product Type: Devices
Issue Date: December 16, 2009
Country: United States

Inspection History, 2009 to 2018

NAI3

VAI2

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.

Kentec Medical, Inc FDA Form 483, Irvine, California, December 16, 2009