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

An FDA inspection of Nephron Sterile Compounding Center LLC, an outsourcing facility in West Columbia, SC, was conducted from March 28, 2022, to April 20, 2022. The inspection, led by Margaret M Annes, CSO, and others, identified several observations.

**Key Observations:**

1. **Failure to Thoroughly Review Discrepancies:** The firm failed to investigate the majority of environmental and personnel monitoring excursions in the ISO 5 environment. From January 1, 2021, to March 31, 2022, approximately 1686 excursions occurred, including 240 related to critical personnel and 51 related to viable air/surface samples in the ISO 5 hood, with 48 of these 51 not investigated.

2. **Deficient Environmental Monitoring System:** * No documentation justified action levels for personnel and environmental monitoring. Investigations were not performed for most excursions below action levels, except for objectionable organisms. * A desiccation study for viable air sampling plates lacked a written/approved protocol and failed to demonstrate microbial growth support after the determined time limit.

3. **Inadequate Sterility Test Procedures:** Test procedures for sterility were not written and followed.

4. **Inadequate Aseptic Process Validation:** * Media fills did not simulate all stressful conditions, such