FDA 483 - Nephron Sterile Compounding Center LLC - April 20, 2022
Discuss this record with AI
Document or profile
One record shows the event. A profile shows the pattern.
Buy this document for the source file and details behind this single event.
Choose full profile access to connect related records, sites, people, citations, and enforcement history in one view.
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.
ID · a1ade3d7-b938-49d1-8f6d-092e3d4e1655