CoRE labs, LLC

Form 483FOIA Uncovered

Englewood, Colorado, United StatesFEI 3001620005Issued April 11, 2019

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 3001620005.

Observations3

Issue DateApril 11, 2019

StatusNo Warning Letter

Related Inspections5

Establishment Details

Firm: CoRE labs, LLC
Location: Englewood, Colorado, United States
FEI Number: 3001620005
Product Type: Devices
Issue Date: April 11, 2019
Country: United States

Inspection History, 2012 to 2023

VAI4

OAI1

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.

CoRE labs, LLC FDA Form 483, Englewood, Colorado, April 11, 2019