NerPharMa S.r.l. – FDA EIR, Feb 20, 2023

An FDA inspection of NerPharMa S.r.l., a drug product manufacturer located in Nerviano, Italy, was conducted from February 6 to February 20, 2023. This preannounced inspection focused on Current Good Manufacturing Practice (CGMP) compliance for injectable drug products, under the regulatory framework of Compliance Programs 7346.832 and 7356.002. The inspection identified nine significant deficiencies, documented on Form FDA-483. Major violations included a lack of established procedures to prevent microbiological contamination in sterile drug products, alongside inadequate environmental monitoring in aseptic processing areas, specifically the Grade A Filling line. Laboratory control issues were noted, with incomplete records lacking full data and scientifically sound test procedures. Electronic record systems failed to meet requirements for retention, access limitation, audit trails, and data reliability. Furthermore, the company demonstrated a failure to thoroughly investigate unexplained discrepancies or out-of-specification batches, and personnel training was found to be insufficient. Calibration procedures for critical equipment also lacked necessary detail for accuracy, precision, and remedial actions. The inspection's classification is "Official Action Indicated" (OAI), with a recommendation for a Warning Letter from DFPQI. NerPharMa S.r.l. acknowledged the observations and committed to submitting a written response detailing corrective actions within fifteen working days, highlighting the need for comprehensive remediation to meet regulatory expectations.