FDA 483 - LSNE-Leon, SLU - October 16, 2018

During an inspection conducted from October 8-11, 15, and 16, 2018, the U.S. Food and Drug Administration (FDA) issued a Form 483 to Gadea Biopharma S.L., a contract sterile injectable drug products manufacturer located in León, Spain. The inspection identified several significant issues related to manufacturing processes, facility readiness, and data integrity.

Key observations included discrepancies between the submitted drug application and actual on-site capabilities. Specifically, the firm's application stated readiness for primary packaging and vial labeling, but no labeling equipment was present, and existing equipment was not qualified for commercial operations. Furthermore, the company lacked established written procedures for managing labeling and packing activities, including controls for issuance, receipt, storage, and ensuring correct label usage.

Critical data integrity concerns were also noted. Certificates of Analysis (COAs) submitted in the drug application did not consistently match raw analytical data and specification sheets for product impurities across several batches. The original COA records for these batches were unavailable on-site. Additionally, the firm lacked a written procedure for tracking changes in COA versions, leading to multiple undocumented versions without unique identifiers.

To address these observations, Gadea Biopharma S.L. is required to implement comprehensive corrective and preventive actions. These actions should rectify the identified deficiencies in facility readiness, procedural controls, and data management practices to ensure compliance with regulatory standards for drug manufacturing.