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Warning Letters Special Report: A Focus On Sterility Risks From Water Systems, Open Cleanrooms

 
• 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
a field day for contamination • Source: Shutterstock

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

Of the 82 drug GMP warning letters the FDA issued last year, 25 addressed shortfalls related to sterility, making it the third most common problem area after investigations and testing

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