FDA EIR - Lonza Biologics Porrino SL - September 13, 2016

An FDA pre-approval inspection was conducted at Lonza Biologics Porriño, S.L. (LBP) in Spain from September 5 to September 13, 2016. This inspection was critical for assessing LBP as an additional manufacturing and quality control testing site for a bulk drug substance, in support of its potential approval for the U.S. market. The regulatory framework for this review involved compliance with CP 7346.832 for Pre-Approval Inspections/Investigations and ICH Q7 guidelines for active pharmaceutical ingredients. During the inspection, the FDA issued a Form 483, outlining five main observations. Key issues identified included inadequate investigations into deviations from established procedures, and deficient documentation verification activities. Furthermore, the facility's Standard Operating Procedures were found to be insufficient, and cleaning validation studies for manufacturing equipment were deemed inadequate. Finally, personnel environmental monitoring practices required improvement. These observations highlight significant areas where LBP must implement robust corrective and preventive actions to enhance its quality systems and ensure full compliance with current Good Manufacturing Practices before the product can be approved for distribution in the United States.