FDA 483 - Nephron Sterile Compounding Center LLC - September 25, 2024

An FDA inspection of Nephron Sterile Compounding Center LLC in West Columbia, SC, revealed significant deficiencies in aseptic processing and quality control. Observations included inadequate procedures to prevent microbiological contamination, insufficient environmental monitoring, and failures in investigating product discrepancies and complaints. The facility also lacked proper differential air pressure monitoring and maintained uncleanable surfaces in aseptic areas, indicating a high risk to product sterility and patient safety.