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[DOI] [PMC free article] [PubMed] [Google Scholar] 116.Kokot A., Zlatar M., Stupnisek M., Drmic D., Radic R., Vcev A., Seiwerth S., Sikiric P
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For example, the warning letter to Curexa includes a section on corrective actions, noting that FDA “cannot fully evaluate the adequacy of the following corrective actions described in your [Form-483] response because you did not include sufficient information or supporting documentation.” 12 The agency then goes on to list specific observations from the Form-483 with a detailed description of why Curexa’s responses were not sufficient
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Keep missing information visible instead of filling it with guesses. Use the table to support judgment rather than replace it.
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