FDA EIR - Aero-Med LLC - December 21, 2018

A routine FDA inspection of Aero-Med Medical Inc., a manufacturer of Class II medical devices, was conducted from December 18-21, 2018, in Glastonbury, CT. The inspection, focusing on bone marrow specimen collection kits, identified two main violations documented on a Form FDA-483. Firstly, the company's Device History Records for these kits lacked Unique Device Identification (UDI), which is a requirement under 21 CFR 820.184(f). Management acknowledged that these products were not currently identified with UDI. Secondly, the Device Master Record for the bone marrow specimen collection kits did not include the necessary management approval for critical documents like the Bill of Materials, assembly map, and work instructions, in violation of 21 CFR 820.181. This highlights a lapse in adhering to the FDA's Quality System Regulation for medical device manufacturing. Company management, specifically the Director of Operations, understood the observations, promised to implement corrections, and was advised of the option to provide a formal written response to the FDA within 15 business days. No recalls or refusals were reported during this initial inspection.