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Should Commitments Made to the FDA Be Taken Seriously?

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There’s no excuse for poor responses or missed deadlines

Responses to the Food and Drug Administration’s (FDA) Warning Letters and the FD483—a written notice of deficiencies found during inspections—are usually full of commitments. They involve what will be done to correct compliance problems, and when it will be done. The FDA has even started to ask how they will be done—i.e., do you have the resources to do the work?

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