FDA 483 - ARG Laboratories, Inc. - September 20, 2023

An FDA inspection of ARG Laboratories, Inc., an OTC Drug Manufacturer in Dallas, TX, revealed severe deficiencies across multiple critical areas. The firm lacks a functional quality control unit, fails to validate manufacturing processes and equipment cleaning, and has released numerous drug products that did not meet assay specifications. Additionally, the company's laboratory controls are inadequate, it relies on unverified supplier analyses for raw materials, uses expired components, and does not perform stability studies to determine product expiration dates.