FDA 483 - Aero-Med LLC - October 26, 2023

Aero-Med LLC, a medical device manufacturer in East Hartford, CT, was cited for two significant observations during an FDA inspection. The firm failed to establish adequate procedures for purchasing controls, leading to critical components being received from unapproved vendors without proper inspection or storage documentation. Additionally, the company lacked established procedures to control environmental conditions for these critical manufacturing materials, including inventory and expiration controls.