FDA 483 - AMCO International Manufacturing & Design, Inc. - May 27, 2021

AMCO International Manufacturing & Design, Inc., a medical device manufacturer in Brooklyn, NY, was cited for two significant issues during an FDA inspection. The firm failed to maintain written Medical Device Reporting (MDR) procedures, including lacking an eMDR procedure and an Electronic Submissions Gateway account. Additionally, the company did not properly document the approval of numerous standard operating procedures with required signatures and dates.