FDA 483 - Emergent BioSolutions Canada Inc. - September 13, 2019

This FDA Form 483 document details an inspection observation at an unnamed facility manufacturing a sterile drug product, "[redacted] Injection, [redacted] mg/mL [redacted] lot # [redacted]." The inspection occurred on September 6, 2019.

The sole observation, "OBSERVATION 1," indicates that "Procedures designed to prevent microbiological contamination of drug products purporting to be sterile are not followed." Specifically, during the filling equipment setup for the aforementioned sterile injection, a Lead Manufacturing Assistant was observed violating the facility's gowning procedures. The individual grasped the *outside* of their sterile boot covers to unfold the vinyl boot soles. This action directly contradicts the firm's established procedures, which mandate that employees only place their sterile, gloved hands *inside* the sterile boot covers and grasp the vinyl boot sole *from inside* to unfold it. This finding highlights a deficiency in adherence to critical aseptic processing procedures designed to maintain the sterility of the drug product.