FDA 483 - AMCO International Manufacturing & Design, Inc. - March 20, 2024

AMCO International Manufacturing & Design, Inc. in Brooklyn, NY, a manufacturer of Class III AED batteries, was cited for significant deficiencies in its quality system. Observations included a deficient design history file for a new AED battery, inadequate process controls for ESD-sensitive components, and a lack of documented equipment calibration and maintenance. These issues indicate a serious lack of control over critical manufacturing processes and product design.