FDA EIR - Precision Dose Inc. - September 11, 2025

An FDA surveillance inspection of Precision Dose Inc., a repacker of prescription and over-the-counter human drug products, was conducted from September 8-11, 2025. The inspection, performed under regulatory guidelines for drug manufacturing and repackaging (CPGM 7356.002 and 7356.002B), focused on the company’s quality, facilities, equipment, production, materials, and laboratory control systems. The inspection identified two significant issues documented on a Form FDA 483, Inspectional Observations. The first observation noted that the company's quality unit was not adhering to its established written procedures, particularly regarding the timely conclusion of customer complaint investigations. This issue was a repeat observation from a prior FDA inspection in 2019. The second observation highlighted that compounding and storage containers, processing lines, and major equipment used in drug product batch production were consistently not properly identified to indicate their contents and current phase of processing. Precision Dose Inc. acknowledged these observations at the close of the inspection and committed to submitting an initial written response to the FDA within 15 business days, outlining corrective actions.