Panel Advice For US FDA-483 Observations And Warning Letters – Analysis And Its Implications

Review of FDA Form 483 issued to manufacturing plant for significant, questionable observations during course of inspection and judgment that constitute violations of the Food Drug and Cosmetic (FD&C) Act and related Acts indicating specific and significant practices indicating final product adulteration thus compromising safety on human health.

Establish comprehensive discussions with company’s management on full understanding of the observations, evidence collected on site during inspection, expeditiously address nature of response and suggestive implementation of corrective action plan.

Review warning letters notified for exclusive violation of the US FDA act with respect to practices, processes, or other activities of regulatory significance, federal statutes, leading to an enforcement of viable action if such documented violations are not adequately or appropriately corrected to determine and protect public health.