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10.1002/nbm.1619 279 ThakareR.KaulG.ShuklaM.KesharwaniP.SrinivasN.DasguptaA.et al (2020)

Here are the recurring topics that keep showing up across pharma manufacturing sites: Inadequate response to Form 483 observations FDA findings A surprising number of organizations waste their 15-day response window by sending generic statements