FDA 483 - Bioiberica, SAU - September 13, 2024

An FDA inspection of Bioiberica, SAU's drug substance manufacturing facility in Palafolls, Spain, revealed significant deficiencies. Observations included a lack of quality unit oversight for maintenance, inadequate equipment cleaning leading to material residue, and insufficient review of deviations and out-of-specification results. Additionally, the firm failed to fully validate laboratory test procedures for pyrogens and total microbial limit tests, specifically for endotoxin release testing.