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Floating Insects in Filling Room Prompt APP Warning Letter
APP Pharmaceuticals received a warning letter for persistent media fill failures and recurring critters in manufacturing areas of the company’s Grand Island, N.Y., plant. The Schaumberg, Ill.-based drugmaker blames its current good manufacturing practice (cGMP) violations on its suppliers, but its deviation investigations were inadequate and APP failed to take appropriate corrective and preventive actions (CAPAs), an FDA warning letter posted Feb. 28 states.
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