483
GlaxoSmithKline Vaccines S.r.l.GlaxoSmithKline Vaccines S.r.l. – FDA 483, Jun 6, 2019
Record Details
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.
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ID · b5f44ae2-4e3a-42a8-bb3e-bf243053fa45
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