FDA 483 - Ava Inc - September 29, 2021

Ava Inc, a drug manufacturer in Willowbrook, IL, was inspected by the FDA and received a Form 483 with two observations. The inspection revealed deficiencies in the firm's labeling procedures, specifically regarding the issuance, control, storage, and destruction of labels for drug products. Additionally, strict control was not exercised over labeling issued for use, with finished product labels found improperly stored outside a locked area.