Corixa Corporation d.b.a. GlaxoSmithKline – FDA 483, Mar 4, 2022

The FDA conducted an inspection of Corixa Corporation, operating as GlaxoSmithKline, a drug manufacturer located in Marietta, PA, from February 28 to March 4, 2022. The inspection resulted in an FDA Form 483, highlighting two significant observations regarding the firm's adherence to manufacturing standards.

The primary concern was the inadequacy of packaging facility inspections following operations, which failed to ensure the complete removal of materials from previous production runs. Despite standard operating procedures for line clearance, the FDA documented multiple instances where labels, unlabeled syringes, and vials from prior batches were discovered after clearances were reportedly completed. Some materials were even found after several clearance attempts, indicating a systemic issue with the effectiveness of the current process.

Additionally, the inspection revealed deficiencies in the company's investigation records for batch failures. Investigations lacked thorough conclusions and follow-up actions, as exemplified by a case where a packaging line vision system failed to detect missing components. The subsequent investigation attributed a root cause but did not adequately assess potentially impacted product shippers to confirm the presence or absence of the missing items.

These observations indicate a need for GlaxoSmithKline to promptly implement comprehensive corrective and preventive actions to ensure the integrity of their packaging operations and the completeness of their quality investigations, thereby maintaining compliance with regulatory expectations under the Federal Food, Drug and Cosmetic Act.