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

From September 16-25, 2024, the FDA inspected Nephron Sterile Compounding Center LLC, an outsourcing facility in West Columbia, SC, owned by Lou Wood Kennedy. The inspection revealed five observations related to production, quality, equipment, and facilities.

**Production System Deficiencies:** * **Microbiological Contamination Prevention:** Procedures to prevent microbiological contamination of sterile drug products are not established. * The syringe filling machine in room 282G allows exposed syringe tips to face the syringe track, potentially creating air currents that circulate particulates around the tips. Products affected include Phenylephrine HCl, Succinylcholine Chloride, Ketamine Hydrochloride, and Rocuronium Bromide injections. * Comprehensive resin bioburden testing from 2022-2024 identified objectionable eukaryotic organisms (e.g., *Aspergillus*, *Penicillium*, *Cladosporium*, *Fusarium*, *Rhizopus*, *Mucor*, *Alternaria*, *Trichoderma*, *Acremonium*, *Paecilomyces*, *Bipolaris*, *Curvularia*, *Epicoccum*, *Phoma*, *Stachybotrys*, *Ulocladium*, *Wallemia*, *Chaetomium*, *Scopulariopsis*, *Geotrichum*, *Rhodotorula*, *Candida*, *Saccharomyces*, *Cryptococcus*, *Pichia*,