Alra, Optopics, Novel water sterility violations draw FDA warning letters.
ALRA LABS "DEAD LEG" WATER STERILITY PROBLEMS DETAILED in a Dec. 9 FDA warning letter. "Dead legs were observed in the deionized water system and our investigators observed dead legs of longer than three feet after the common drop piping," the letter states. The observations were made during facility inspections conducted between Aug. 29 and Oct. 28. Alra generally failed to "establish and follow appropriate written procedures, designed to prevent objectionable microorganisms in [its] non-sterile drug products," the FDA warning letter states.
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