FDA 483 - Associates of Cape Cod, Inc. - April 03, 2025

An FDA inspection of Associates of Cape Cod, Inc., an LAL Reagent Manufacturer in East Falmouth, MA, revealed a significant lapse in quality control documentation. The firm failed to maintain records for annual product reviews of its licensed LAL reagents and Control Standard Endotoxin, as required by their standard operating procedures. This indicates a deficiency in evaluating product quality standards and determining the need for changes in manufacturing or control procedures.