FDA 483 - Associates of Cape Cod, Inc. - November 26, 2019

Associates of Cape Cod, Inc., a contract testing laboratory in East Falmouth, MA, was cited for significant deficiencies in laboratory record retention and quality unit procedures during an FDA inspection. The firm failed to retain complete testing data and did not adequately review and approve investigations within established timeframes. These issues indicate a lack of adherence to good manufacturing practices regarding data integrity and quality system oversight.