FDA 483 - BWXT Medical Ltd - February 23, 2024

During an FDA inspection conducted from February 15 to February 23, 2024, BWXT Medical Ltd., a radiochemicals API manufacturer located in Vancouver, British Columbia, received a Form FDA 483. The inspection revealed a significant observation regarding the company's procedures for ensuring accurate labeling of Active Pharmaceutical Ingredient (API) products. Specifically, the FDA noted that BWXT Medical's procedures designed to assure correct labels are inadequate. This inadequacy was highlighted by a customer complaint on July 31, 2023, concerning an order dispensed with an incorrect pre-printed vial label. This incident marked the second occurrence of mislabeled shipments, following a similar event in March 2019. The company attributed the root cause to human error and a failure to adequately follow Standard Operating Procedure (SOP) 70-027, which outlines responsibilities for customer order disposition. The FDA observation further indicated that the quality control unit failed to ensure this SOP was written with sufficient detail and specificity to prevent such labeling errors. While a Form FDA 483 lists observations and is not a final determination of compliance, BWXT Medical Ltd. is expected to address these critical issues to ensure the integrity of its product labeling and prevent future occurrences, thereby adhering to regulatory expectations for pharmaceutical manufacturing.