FDA 483 - Lil' Drug Store Products, Inc. - June 02, 2022

Lil' Drug Store Products Inc. in Cedar Rapids, IA, received a Form 483 with one observation concerning deficiencies in their quality control unit. The firm failed to establish written quality agreements with contract manufacturers for over-the-counter finished drug products, specifically sterile eye drops, and had not audited one such contract manufacturing site. This indicates a significant lack of oversight for outsourced manufacturing operations.