FDA WARNING_LETTER - ProRx, LLC - August 02, 2024

On December 20, 2024, the FDA issued Warning Letter #696742 to ProRx, LLC, an outsourcing facility located in Exton, Pennsylvania, following an inspection from July 15 to August 2, 2024. The inspection revealed that ProRx, LLC's drug products failed to meet the conditions of section 503B of the FDCA, necessary for exemptions from certain provisions, and exhibited serious deficiencies in sterile drug production, posing patient risks.

Key violations include: - **Failure to meet 503B conditions:** Compounding drugs using bulk substances from an unregistered establishment, inadequate labeling (missing "This is a compounded drug," facility information, established drug name, dosage form, "Office Use Only," and ingredient lists), and insufficient adverse event reporting procedures (lacking definitions for "serious" and "unexpected" events, 15-day reporting requirements, follow-up investigation requirements, and proper reporting methods). - **Adulterated Drug Products (Insanitary Conditions):** Observations included operators blocking first-pass air over uncapped vials, rapid movements near sterile products, bare hands exposed in ISO 5 areas, improper gowning, powering off ISO 5 Biosafety Cabinet (BSC) during cleaning, use of non-sterile wipes, inadequate media fills, no environmental monitoring in ISO 5, insufficient smoke studies, and a flying insect in cleanroom areas.