FDA Intensifies Oversight of OTC Eye Drop Manufacturing Following Recurring Sterility and Contamination Concerns
The U.S. FDA is intensifying oversight of over-the-counter (OTC) eye drop manufacturers following a series of contamination concerns and sterility-related recalls. The regulatory action highlights growing scrutiny of ophthalmic drug manufacturing practices, quality assurance systems, and compliance with current Good Manufacturing Practices (cGMP). Industry stakeholders are expected to face stricter inspections and increased accountability as regulators work to strengthen patient safety and product quality standards.
Jun 17, 2026