FDA EIR - Sever Pharma Solutions - March 31, 2023

An FDA inspection of Sever Pharma Solutions, a foreign contract manufacturer in Malmo, Sweden, producing non-sterile capsule and tablet drug products intended for U.S. distribution, was conducted from March 27-31, 2023. This preannounced Foreign Drug Inspection focused on the company's Quality system, facilities, equipment, active ingredients, production controls, and product release analytical testing, under Good Manufacturing Practice (GMP) compliance programs. Notably, the March 2023 inspection concluded with a "No Action Indicated" (NAI) classification, and no FDA Form 483 (Inspectional Observations) was issued, indicating no significant deficiencies were observed during this specific visit. However, a previous FDA inspection from December 11-15, 2017, did identify significant issues, leading to a four-item Form FDA-483. These included failures to thoroughly review unexplained discrepancies, establish control procedures for manufacturing process variability, ensure electronic record trustworthiness and retention, and demonstrate that equipment surfaces contacting drug products do not compromise product quality. Despite the positive outcome of the recent inspection, the FDA has issued a recommendation for re-inspection, consistent with applicable compliance programs, to ensure ongoing adherence to regulatory standards for drug product manufacturing.