Nephron Sterile Compounding Center LLC – FDA 483, Feb 10, 2023

An FDA inspection conducted at Nephron Sterile Compounding Center LLC from November 8, 2022, to February 10, 2023, revealed significant deviations from manufacturing quality standards for an Outsourcing Facility. The observations, documented in an FDA Form 483, highlighted widespread issues across several critical areas. The firm’s quality control unit was found deficient, lacking comprehensive written procedures and failing to ensure crucial aspects like dynamic smoke studies, validated environmental monitoring limits, proper equipment maintenance, and software/process validations. Additionally, material quarantine procedures were inadequate, and audit trail reviews for electronic data were insufficient, with instances of unreviewed data and reprinted labels without justification. Aseptic processing areas exhibited compromised air quality, including issues with unidirectional airflow, ineffective static smoke studies, and physical defects such as rust and holes in critical equipment. Environmental monitoring technicians used improper sampling techniques, and sampling plans omitted high-risk locations. Further concerns included inadequate controls over computerized systems, with shared logins and lack of audit trails allowing unauthorized changes to critical operating parameters. Inventory management was also severely flawed, showing inaccurate records, storage of drug components in uncontrolled, unmonitored environments, and raw materials that were not properly segregated or accounted for. Personnel displayed poor aseptic techniques, disinfectant efficacy studies were incomplete, and bioburden reduction processes for sterile products lacked validation. Nephron Sterile Compounding Center LLC is required to address these systemic issues by developing and implementing comprehensive corrective actions to ensure the safety and quality of their sterile drug products.