FDA 483 - GlaxoSmithKline Vaccines S.r.l. - June 06, 2019

An FDA inspection of GlaxoSmithKline Vaccines S.r.l. in Siena, Italy, identified three observations. The firm was cited for inadequate control procedures, specifically lacking hold time validations for laboratory materials. Additionally, issues were noted with the identification of lots and deficiencies in equipment cleaning and maintenance procedures, including an inadequately maintained freezer.