Expert: Form 483 Responses Must Set Realistic Deadlines, Detail Each Resolution

Drugmakers should respond separately to each observation made in a Form 483 that contains multiple observations, not with a single comprehensive plan, an expert says.

“The FDA separated [the observations] for a reason,” said Marla Phillips, director of Med-XU at the Xavier University Leadership Center, during an FDAnews webinar. Also, if the agency hasn’t made note of an overarching link between the issues, “you might not want to point that out.”

Drugmakers should set realistic corrective action deadlines, she warned. Missing the deadline is generally only acceptable if scientific issues arise, such as the need to revalidate a procedure.

With the FDA’s new 15-day deadline for Form 483 responses, a good, timely response won’t necessarily stop a warning letter but it may make the agency think twice if the response appropriately addresses all the issues, she said.

For a good response, avoid too many attachments. For example, when revising a portion of a standard operating procedure, include the revised page and state that further information can be provided upon request, she said.

And don’t let verification audits for corrective actions slide. “You know that the FDA is going to come back and do their reinspection to verify, so you need to do it as well, Phillips noted.” — April Hollis