FDA 483 - BPI Labs LLC - April 30, 2021

An FDA inspection conducted at BPI Labs LLC from April 19 to April 30, 2021, revealed several significant deficiencies concerning the manufacturing of sterile drugs and combination products, specifically pre-filled epinephrine syringes. The observations, documented under an FDA Form 483, highlighted a lack of appropriate equipment design and qualification, as a labeling machine for the epinephrine syringes had not been installed or validated for use. Furthermore, the company's supplier management system was found inadequate. BPI Labs LLC failed to properly evaluate and select potential suppliers based on specified requirements, notably for sterile 1ml syringes. The supplier qualification process did not secure essential information, and on-site audits were not conducted or scheduled, contravening internal procedures. The inspection also identified shortcomings in risk analysis for the epinephrine syringe combination product, with an insufficient identification of hazards, estimated risks, and mitigations. Supplier controls for critical components, like glass syringes and rubber plungers, were not adequately assessed. Additionally, procedures for design transfer were not properly established, and a quality agreement defining control over the sterile syringe supplier was absent for an extended period after vendor approval. These observations indicate non-compliance with established quality system principles for drug manufacturing and combination products. BPI Labs LLC is required to implement comprehensive corrective actions to address these findings, ensuring equipment qualification, robust supplier management, thorough risk analysis, proper design transfer, and clear quality agreements to maintain product safety and efficacy.