by ComplianceQuest

My Dashboard Inspection Tracker FDA Guidance Templates Assessments

Sign in Get started

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

ANALYTICS

Tracker Overview Enforcement Themes

FDA ACTIONS

Form 483s Warning Letters Inspections Recalls

AUDIT READINESS

COMPANIES

Companies Facilities

Loading…

Dashboard Warning LettersWarning Letter Details

Island Kinetics, Inc. d.b.a. CoValence Laboratories Warning Letter Details

Warning Letter

Island Kinetics, Inc. d.b.a. CoValence Laboratories

Island Kinetics, Inc. d.b.a. CoValence Laboratories, 460 S. Benson Ln. Suite 1-3 Chandler , AZ 85224-5663 United States

Issue DateJuly 16, 2026

FEI Number3002408934

Violations4

CountryUnited States

Issuing Office

Center for Drug Evaluation and Research (CDER)

Product Type

Drugs

Status

Open

Subject

CGMP/Finished Pharmaceuticals/Unapproved New Drug/Misbranded/Adulterated

Island Kinetics, Inc. d.b.a. CoValence Laboratories FDA Warning Letter, July 16, 2026