FDA 483 - Associates of Cape Cod, Inc. - October 21, 2021

Associates of Cape Cod, Inc., a manufacturer in East Falmouth, MA, was inspected by the FDA. The inspection revealed a significant issue regarding the firm's quality system, specifically the inadequate documentation of corrective and preventive action activities. This included a failure to document CAPA for a specific recall, indicating a lapse in adherence to their own established procedures.