The US Food and Drug Administration (FDA) lambasted India-based Global Pharma Healthcare in a 14 November warning letter for manufacturing eye drops that have been linked to an outbreak of bacterial infections resulting in consumer injury, blindness, and at least three deaths. In a related enforcement action, FDA also rebuked Amazon for making unapproved drug claims.
FDA’s list of contaminated eye drops continues to grow, signaling that the problem is not going away anytime soon. The agency on 16 November updated its list of OTC products consumers should not buy or use due to the risk of infection which could lead to full or partial vision loss.
The agency has responded to the situation by issuing recent guidance recommending a battery of studies that manufacturers can use to assess the quality of topical ophthalmic drugs (RELATED: FDA issues guidance on assessing quality of topical ophthalmic drugs, Regulatory focus 16 October 2023)…
