FDA 483 - Associates of Cape Cod, Inc. - November 08, 2018

Associates of Cape Cod, Inc., an IVD manufacturer in East Falmouth, MA, was cited for multiple deficiencies during an FDA inspection. Observations included inadequate procedures for non-conforming product, environmental controls, process validation, complaint handling, and maintaining sanitary storage conditions. These issues indicate a lack of robust quality system controls across several critical manufacturing and storage operations.