FDA 483 - BPI Labs LLC - April 30, 2021

An FDA inspection of BPI Labs LLC in Largo, FL, a sterile drug manufacturer and 503B outsourcing facility, revealed multiple deficiencies in equipment qualification, supplier management, and risk analysis. The firm failed to install and qualify labeling equipment, adequately evaluate suppliers for critical components, and conduct comprehensive risk analyses for its combination products. These observations indicate significant issues in the firm's quality system and compliance with regulatory requirements.