An industry shift has led toward more insourcing and in-house resources to run trials.
Laurie Halloran
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Articles by Laurie Halloran
If an FDA investigation results in a Form 483 then it is important to prove that earlier issues have been resolved upon re-inspection. The following steps using your Corrective and Preventive Action (CAPA) program are crucial to appropriately handling and responding to an FDA Form 483 in helping avoid a Warning Letter.
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