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.
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Firm’s problems “illustrate just how important it is for senior managers to prioritize manufacturing quality, to prioritize patient safety and prevent the absolutely tragic consequences that resulted here,” says Don Ashley, CDER compliance office director.