Deleted Tweet from Scott Gottlieb, R-D.C.
Deleted Tweet from Scott Gottlieb, M.D.
SteveFDA (R-D.C.)
@SGottliebFDA
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The pre-market inspection looks at whether the facility is capable of manufacturing the drug in the product application; has personnel and procedures in place to preserve the drug’s identity, strength, quality and purity; and has appropriate systems to ensure data reliability.
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