Get Social With Us

Responding to an FDA 483 form

By: T. Burtis
Reprinted with the permission of BioProcess International, February 2016

BPTC Senior Consultant Taylor Burtis recommends a straight forward, five step process for managing a company’s response to the issuance of an FDA 483. Earlier in her career, she held senior-level regulatory positions in the biopharmaceutical industry as well as serving as a FDA Consumer Safety Officer in the Office of Compliance at the Center for Biologics Evaluation and Research (CBER). Her background gives her a unique perspective on the topic. Taylor recommends that regulatory compliance executives view the Form 483 experience as a learning opportunity, while considering the 483 as an audit report that they didn’t have to pay for directly.