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

An FDA Level II inspection of Associates of Cape Cod, Inc. (ACC) in East Falmouth, MA, was conducted from October 31 to November 8, 2018, under the regulatory framework of Compliance Program 7342.008 for licensed in-vitro diagnostic devices. The inspection focused on the company's manufacture of Limulus Amebocyte Lysate (LAL) reagents and Fungitell, a Class II medical device.The inspection identified significant good manufacturing practice (GMP) deficiencies, resulting in an FDA Form 483 with multiple observations. Key violations included inadequate procedures for controlling non-conforming products, specifically releasing a Pyrotell lot despite an unvalidated sterility failure investigation. Environmental controls in ISO 5 fill rooms were deficient, lacking comprehensive monitoring and updated disinfectant validation. The automated dishwashing process for manufacturing equipment was not properly validated with defined loading patterns. Furthermore, the company's complaint handling system was found lacking, as evidenced by insufficient investigation into product temperature excursions during shipping and failure to notify all affected customers about mispackaged Fungitell kits. Storage areas exhibited unsanitary conditions, with debris and insects present in both cold storage and warehouse facilities.Management was informed of these findings and is required to formally respond to the FDA 483 observations within 15 business days, outlining their proposed corrective and preventive actions to rectify these regulatory non-compliances.