FDA 483 - Access Business Group LLC - June 24, 2022

Access Business Group LLC in Ada, MI, a drug manufacturer, was inspected by the FDA from June 15-24, 2022, resulting in two observations. The inspection revealed deficiencies in batch production records, which lacked complete information for critical steps, and issues with equipment storage, where portable vessels were exposed to a dusty atmosphere, posing a risk of cross-contamination.