113 – Regulatory Inspections & Audits (S8E8)

This episode outlines the inspection and audit processes used by regulatory agencies, such as the FDA, to ensure compliance with regulations in drug manufacturing and clinical trials. The conversation covers preparation for inspections, the conduct of audits, and follow-up steps. Documented examples highlight key aspects of the process.

We highlight real-world examples of enforcement actions, including Form 483 observations, warning letters, and consent decrees, to illustrate the consequences of non-compliance. The discussion emphasizes the importance of maintaining meticulous records, adhering to Good Manufacturing Practices (GMP), and establishing robust quality systems. The episode also highlights sanction activities and the enforecment power of the FDA.