FDA 483 - GlaxoSmithKline Manufacturing S.p.A. - November 12, 2021

During an inspection conducted from November 8 to 12, 2021, the U.S. Food and Drug Administration (FDA) issued a Form 483 to GlaxoSmithKline Manufacturing S.p.A., a drug product manufacturer located in San Polo di Torrile, Parma, Italy. The inspection revealed multiple instances where Standard Operating Procedures (SOPs) were either not followed or were deemed inadequate for maintaining proper control over critical manufacturing processes.Key observations highlighted deficiencies in aseptic techniques and environmental controls within the sterile manufacturing areas. Specifically, the FDA noted improper material handling during the setup of the filling line, including the potential contamination of primary packaging due to incorrect unwrapping procedures and the introduction of unsanitized environmental monitoring plates into Grade A areas. Furthermore, operators failed to don fresh sterile gloves for critical interventions, increasing contamination risks.Sanitization practices for Restricted Access Barrier Systems (RABS) were also found to be deficient, as wipes were not consistently folded to an unsoiled surface during cleaning, potentially spreading contaminants. Personnel monitoring for microbial contamination was inadequate; glove sampling procedures did not ensure full contact with contact plates or cover both sides of ambidextrous gloves. Additionally, personnel in Grade B aseptic areas did not consistently maintain appropriate hand placement, contrary to aseptic principles, and relevant SOPs lacked clarity in this regard.These observations indicate a need for GlaxoSmithKline Manufacturing S.p.A. to implement robust corrective actions, revise and enhance its SOPs, and improve training to ensure full compliance with regulatory expectations for drug product manufacturing.