In this article Steve Lynn from Regulatory Compliance Associates discuss why the top 10 FDA Form 483 issues have remained mostly the same for the past twenty-three years and how the industry can solve these systemic repeat observations.
A Discourse on Pharmaceutical cGMP FDA Form 483 Trends: Why are We Re-Living the Same Issues Over the Last 23 Years?
Published In: American Pharmaceutical Review
June 24, 2022
Steve Lynn
Executive Principal Consultant, Pharma and Biologics
Steve has over 20 years of quality- and regulatory-compliance experience in the pharmaceutical, biopharmaceutical, medical device, blood, plasma, and tissue industries. He is an expert in compliance matters related to Current Good Manufacturing Practices (CGMP) and has significant experience with other GxP quality- and regulatory-compliance issues.
