BPI Labs LLC – FDA 483, Feb 21, 2025

This FDA Form 483 document details an inspection observation at an outsourcing facility. The primary finding, Observation 1, indicates that the labels of the facility's drug products are deficient. Specifically, the labels do not include information required by section 503B(a)(10)(A) of the Federal Food, Drug, and Cosmetic Act (FD&C Act). This observation points to a non-compliance issue with labeling requirements for drug products manufactured by the outsourcing facility. The document does not provide details on other observations, the facility's name, location, or the date of the inspection. It solely focuses on the labeling deficiency as a violation of the specified section of the FD&C Act, implying a need for the facility to revise its labeling practices to meet regulatory standards.