FDA 483 - First Time US Generics LLC - January 12, 2024

An FDA inspection of First Time US Generics LLC in Broomall, PA, revealed significant deficiencies in equipment cleaning and preventative maintenance procedures. The firm failed to perform preventative maintenance according to manufacturer specifications and lacked validation for clean hold times and alcohol wipe steps, potentially impacting drug product quality. These issues indicate a failure to prevent malfunctions and contamination of drug products.