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The FDA investigator noted that the required validations of media fills, stability, equipment, clean room and processes were either not being done or were inadequate. Read More
An Ohio company violated federal regulations for medical devices by making claims for its product that were not approved by the FDA, the agency said in a warning letter. Read More
A company that manufactures EpiPens neglected to follow up on hundreds of complaints that the epinephrine injectors failed to operate during life-threatening emergencies, including some that resulted in patients’ deaths — and the company did not recall potentially defective injectors from the marketplace even after identifying a fault in a critical injector component, the FDA said in a warning letter. Read More
The firm’s device history record did not indicate that its class II heat therapy pump was manufactured according to the device master record. Read More
The FDA said it could find no evidence that tubes made by Becton Dickinson for Magellan Diagnostics’ blood lead-level testing devices contributed to inaccurate readings from the devices, which Magellan had suggested as a cause. Read More