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

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.

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