FDA 483 - ProRx LLC - August 02, 2024

An FDA inspection was conducted at ProRx LLC, an outsourcing facility in Exton, PA, from July 15, 2024, to August 2, 2024. The FDA Form 483 report detailed several significant observations regarding the firm's operations. A primary concern was the failure to establish, write, and follow adequate procedures to prevent microbiological contamination of sterile drug products. Specific issues included an operator blocking critical airflow over uncapped vials during sterile filling and the Pharmacist-in-Charge (PIC) demonstrating poor aseptic technique, such as prodding sterilized caps with forceps near open product, exposing bare hands in a sterile environment before donning gloves, and inadequate gowning practices (bending to the floor in the anteroom then only spraying gloves). Additionally, the ISO 5 Biosafety Cabinet, crucial for maintaining sterility, was observed to be powered off when not in use and during cleaning processes. The firm was also cited for failing to submit required product reports upon its initial registration in April 2022, specifically for June and December 2022. These observations suggest potential non-compliance with the Federal Food, Drug, and Cosmetic Act, and ProRx LLC is expected to implement thorough corrective and preventive actions to address these deficiencies and ensure product quality and safety.