FDA 483 - GlaxoSmithKline Manufacturing S.p.A.

GlaxoSmithKline Manufacturing S.p.A., a drug product manufacturer in San Polo di Torrile, Parma, Italy, was cited for significant deficiencies in its aseptic processing operations during an FDA inspection. The inspection revealed multiple instances where Standard Operating Procedures were either inadequate or not followed, leading to potential contamination risks in critical manufacturing areas. These issues included improper material handling, inadequate sanitization practices, and insufficient personnel and environmental monitoring.