Manufacturers May Shift Focus on 483 Response Deadline

The faster FDA Form 483 response deadline may not be a greater burden to manufacturers because they can focus on monitoring and anticipating inspection issues and set realistic goals for their responses before and after the deadline. “I think people are pressured to feel that in 15 days you have to have the whole answer” to Form 483 observations, Liz Troll, principal of Troll Advisory Group, said at FDAnews’ First Annual CAPA Congress in Rockville, Md. A good response would include a realistic commitment with promised follow-up action, she added.
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