LSNE-Leon, SLU – FDA EIR, Jan 17, 2020

A pre-approval inspection (PAI) of Lyophilization Services New England (LSNE)-Leon, a contract sterile drug manufacturer in Leon, Spain, was conducted by the FDA from January 13-17, 2020. This inspection, part of the Office of Pharmaceutical Quality Operations' FY20 work-plan and CDER's PAI program, focused on assessing the firm's readiness for commercial manufacturing and conformance to drug applications for sterile-filled small volume parenteral drugs, with a limited data integrity audit. This specific inspection did not include a Good Manufacturing Practices (GMP) component.

A previous FDA inspection in October 2018 had resulted in a Form FDA 483, citing multiple observations. Key issues included discrepancies between submitted drug application information and on-site capabilities, specifically the absence of vial labeling equipment and procedures despite the application stating LSNE-Leon performed these operations. Furthermore, the firm lacked qualified labeling equipment for commercialization, written procedures for labeling and packing, and proper documentation control for Certificates of Analysis.

In contrast, the recent January 2020 inspection concluded without the issuance of a Form FDA 483, though verbal observations were communicated to management. Consequently, the FDA classified the inspection as "No Action Indicated" (NAI) and recommended approval for the application under review. The firm is slated for follow-up on a routine surveillance basis, and the Office of Regulatory Affairs is to issue the formal PAI letter.