483
BWXT Medical LtdFDA 483 - BWXT Medical Ltd - February 23, 2024
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Record Details
BWXT Medical Ltd, a radiochemicals API manufacturer in Vancouver, British Columbia, was cited for inadequate procedures to ensure correct labeling of API products. The inspection revealed repeated instances of erroneously pre-printed vial labels, attributed to human error and a quality control unit's failure to detail standard operating procedures sufficiently. This indicates a significant issue with label control and quality assurance processes.
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ID · 9447e311-4757-4fcc-bc1f-a649a7ddbb6e