FDA 483 - Automated Ophthalmics, Inc. - February 13, 2026

An FDA inspection of Automated Ophthalmics, Inc. in Elkridge, MD, a manufacturer of Softips Plus Tip Covers, revealed significant deficiencies across multiple quality system areas. Observations included the absence of unique device identifiers on product labels, inadequate protection of products from temperature damage during storage and shipping, and systemic failures in complaint handling and nonconforming product evaluation processes. These issues indicate a lack of robust quality controls that could impact product integrity and patient safety.