Eye Drop Manufacturers Get Advice On Seeing Quality Clearly In US FDA Draft Guidance
Need for guidance shown not only in recalls over past year of OTC eye drops due to bacterial contaminants found in products and insufficient sterility practices in facilities but also in warning letters sent in 2022 and 2023 to firms manufacturing Rx and OTC ophthalmic drugs.
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Common across warnings is all the firms, retailers as well as manufacturers, are marketing OTC eye drops with noncompliant claims, including “prevent or improve cataracts” and “temporarily alleviate blepharitis symptoms.” One also had GMP problems.
Agency warns two drug firms providing OTC eye drops about failing to maintain sanitary conditions after early in 2023 announcing Indian firm Global Pharma Healthcare made artificial tear products recalled due to potential infection from bacterial contamination not previously seen in US.
Agency wants time to ensure compliance with GMP regulations before drug makers, such as an Indian firm which provided artificial tear eye drops currently on recall in the US after the products were linked to serious adverse events, distribute OTC monograph drugs for the first time.