FDA 483 - Nephron Sterile Compounding Center LLC - April 20, 2022

Nephron Sterile Compounding Center LLC in West Columbia, SC, was cited for significant deficiencies during an FDA inspection. The observations primarily concern inadequate investigations into environmental and personnel monitoring excursions, microbiology lab issues, and stability failures. Additionally, the firm failed to properly validate aseptic processes, maintain required records, and ensure proper verification in laboratory testing, while also compounding unapproved bulk drug substances.