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

On June 25, 2024, the FDA issued a Warning Letter to Adam Milewski, following an inspection of their firm at 410 Conselyea Street, Brooklyn, NY, from March 11 to March 20, 2024. The firm manufactures replacement batteries for Automated External Defibrillators (AEDs), including AMCO Part Numbers AM9146-2, AM5070, AM1000, 5L318, 6L785, 5L500, and AM9141. These products are classified as devices under section 201(h) of the Federal Food, Drug, and Cosmetic Act (the Act).

The primary violation identified is the distribution of unapproved devices. A final order effective February 3, 2015, required Premarket Approval (PMA) applications for AEDs and necessary AED accessories, with a compliance date for accessories extended to February 3, 2022, due to COVID-19. The inspection revealed the firm manufactures and distributes AED batteries (AM9146-2, AM5070, AM1000, and others) without submitting the required PMA by the February 3, 2022, deadline. Consequently, these devices are adulterated under section 501(f)(1)(A)