FDA 483 - Nephron Sterile Compounding Center LLC - April 21, 2017

On April 21, 2017, the FDA issued a Form 483 to Nephron Pharmaceuticals Corporation, an outsourcing facility located in West Columbia, SC, following an inspection from April 17-21, 2017. The inspection identified four observations related to laboratory control, quality systems, and packaging/labeling.

**Laboratory Control System:** 1. **Sterilization Process Validation:** The firm failed to adequately validate the sterilization process for sterile drug products. Specifically, aseptic process simulations were not performed to validate the Phenylephrine Hydrochloride aseptic sterilization process, failing to assure sterility throughout the process. 2. **Test Procedures and Visual Inspection:** Laboratory controls lacked scientifically sound and appropriate test procedures. * The "Visual Inspection of Compounded Sterile Preparations" procedure (SQE.OC A30L, version 1.0) and operators performing 100% visual inspection lacked a representative library of potential defects for training and qualification. * The firm had not defined defect categories for visual inspections or performed trending of such defects for continuous process quality improvements.

**Quality System:** 3. **Quality Control Unit Procedures:** Responsibilities and procedures of the quality control unit were not fully followed. The firm had not established a required element of its Quality Program, with reviews not being conducted as per SOP.

**Packaging and Labeling System:** 4. **Container Label Deficiencies