FDA 483 - Specialty Formulations & Manufacturing, LLC - September 12, 2025

Specialty Formulations & Manufacturing, LLC in Phoenix, AZ, a drug manufacturer, was cited with four observations during an FDA inspection. The firm lacks a functional quality control unit and adequate written procedures for equipment cleaning, raw material testing, and production process controls. These deficiencies indicate significant issues with the firm's adherence to cGMP regulations, potentially impacting drug product quality.