FDA 483 - Bioiberica, SAU - September 13, 2024
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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.
ID · 183571fe-a614-4e7f-82d1-c38d1b9a58b4