483
Boston Medical Products, Inc.FDA 483 - Boston Medical Products, Inc. - July 12, 2023
Record Details
An FDA inspection of Boston Medical Products, Inc., a distributor in Shrewsbury, MA, revealed a significant procedural deficiency. The firm failed to develop written procedures for the surveillance, receipt, evaluation, and reporting of post-marketing adverse drug experiences for its approved drug product, Steritalc. This indicates a lack of essential controls for drug safety reporting.
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ID · 3eb883c3-4e57-4c56-a540-2802f6a2000a