by ComplianceQuest

Inspection Tracker

Tracker Overview Enforcement Themes Form 483s Warning Letters Inspections Recalls Investigators Companies Facilities

FDA Guidance Global Templates

Start with a Free ConsultationBook 30 minutes with a ComplianceQuest specialist.Book a Call

Sign In Create a Free Account

Big News: FDA is moving from MasterControl to ComplianceQuest.See Why

Search AgentQ/

Talk to a Specialist

Loading…

My DashboardInspection TrackerForm 483sQualgen LLC

Qualgen LLC

Form 483

Oklahoma, United StatesFEI 30112866349Issued June 15, 2021

View Form 483 PDF

Source: FDA, document on file. FDA released the Form 483 itself. The document linked above is our copy of FDA's file, stored by us so the link cannot break, and FDA's own copy is linked beside it. To check it, open FDA's record for this establishment on FDA's Data Dashboard, listed under FEI 30112866349.

Observations15

Issue DateJune 15, 2021

StatusNo Warning Letter

Establishment TypeOutsourcing Facility

Related Inspections0

Establishment Details

Firm: Qualgen LLC
Location: Oklahoma, United States
FEI Number: 30112866349
Establishment Type: Outsourcing Facility
Product Type: Outsourcing Facility
Issue Date: June 15, 2021
Country: United States

Inspection History

We hold no FDA inspection matched to this establishment.

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.

Qualgen LLC FDA Form 483, Oklahoma, June 15, 2021