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US Warnings Show Focus On Sterility Risks From Water Systems Following OTC Drug Firm's Problems

 
• By Bowman Cox

A B. cepacia contamination recurrence led the US FDA to double down on sterility assurance of water systems in 2022, a trend likely to continue, Part 7 of our series finds. Open cleanroom contamination continued to drive warning letters as Annex 1 policy revision adds incentives to separate workers from injectable drug products with access barriers or isolators.

2022 Warning Letters Special Report
• Source: Shutterstock

Many US Food and Drug Administration drug warning letters in 2022 raised concerns about inadequate sterility assurance, particularly for water systems and traditional open clean rooms.

The agency's emphasis on water systems came as a recalcitrant CEO of a firm making OTC drugs insisted on using

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