Abbott Laboratories received a warning from the FDA that its California plant for producing monitors of blood-sugar levels violate regulatory standards. FDA investigators reported that an inspection showed Abbott’s Freestyle and Navigator blood glucose-monitoring devices did not conform to quality manufacturing practices and thus were adulterated. An Abbott spokesman said the warning letter would not affect the continued marketing of the devices, and related only to the firm’s validation and documentation procedures. The spokesman said Abbott was taking corrective actions. (Click here for more)
“FDA Warns Abbott On Blood-Sugar Monitors” – Reuters (7/20/10)
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