FDA 483 - Alick's Home Medical Equipment, Inc. - September 03, 2021

Alick's Home Medical Equipment, Inc. in South Bend, IN, a drug manufacturer, was inspected and cited for multiple deficiencies related to its medical oxygen production. The inspection revealed significant issues with batch production records, adherence to written procedures for component receipt, complaint handling, quality control unit responsibilities, and GMP training. These observations indicate a lack of control over critical manufacturing and quality processes.