FDA 483 - Merck Sharp & Dohme LLC - April 16, 2021
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Merck Sharp & Dohme Corp. in Durham, NC, received a Form 483 with six observations during an FDA inspection from April 7-16, 2021. The observations highlight significant deficiencies in equipment maintenance, facility upkeep, quality control unit authority, batch record documentation, equipment routine checking, and written production procedures for vaccine manufacturing. These issues pose risks to the quality and purity of vaccine products like Varivax, Zostavax, and MMR II.
ID · 8eeb13af-941d-45fe-be1d-581c3e337c75