Two days after publishing a warning to an Indian firm about widespread insanitary manufacturing conditions, US regulators identified a second firm in Inda with similar problems in its production of OTC eye drops marketed in the US.
Second Indian Firm's Eye Drops Recalled In US
All lots of nearly 30 different dry eye and lubricating products made by Mumbai-based Kilitch Healthcare India and sold in US by major drug store chains and marketed under multiple private label brands are recalled after FDA investigators found insanitary conditions at firm’s facility.
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FDA testing of 95 benzoyl peroxide products due to concerns about elevated benzene detected by third-party testers found 90% with undetectable or extremely low benzene levels.
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Regenerative Processing replaces nozzle to prevent backflow for its Regener-Eyes drops but FDA warning states numerous questions about sterility at the firm’s plant and about its procedures and systems for preventing microbial contamination.
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Streamlined process for reporting problems is key piece of “unified Human Foods Program” which officially launched on 1 October, as Commissioner Robert Califf says, “a new model for field operations and other modernization efforts.”
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HBW Insight speaks to AESGP director general Jurate Švarcaite about what's on the agenda for the upcoming 61st AESGP Annual Meeting, which will take place in Warsaw, Poland, between 2-4 June. Highlights include the role of prevention in self-care, discussions about how regulators will ensure the competitiveness of European industry on the world stage and incoming changes to sustainability legislation.