Maloney's Custom Ocular Prosthetics

Form 483

Lake Oswego, Oregon, United StatesFEI 3000207198Issued December 05, 2012

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 3000207198.

Observations3

Issue DateDecember 05, 2012

StatusNo Warning Letter

Related Inspections3

Establishment Details

Firm: Maloney's Custom Ocular Prosthetics
Location: Lake Oswego, Oregon, United States
FEI Number: 3000207198
Product Type: Devices
Issue Date: December 05, 2012
Country: United States

Inspection History, 2010 to 2015

NAI1

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.

Maloney's Custom Ocular Prosthetics FDA Form 483, Lake Oswego, Oregon, December 5, 2012