Recent Product Recall

FDA announced one voluntary, company-initiated recall. A pharmaceutical company recalled certain lots of a drug for injection due to potential presence of glass particulate matter in vials produced by a contract manufacturer.

Click here for a complete listing of FDA Recalls.

Recent Warning Letters

Since the last Update, FDA cited one facility for failure to pay the facility fee as required by the Generic Drug User Fee Amendments Act of 2012.

FDA cited two medical device manufacturers for violating Quality System Regulation ("QSR") requirements. The warning letter to the first manufacturer included other violations, such as failure to ensure the presence of identification labels on each device product, failure to establish Device Master Records and Device History Records containing the required information for the devices, and failure to ensure manufacturing equipment is calibrated. FDA warned the second manufacturer for violating Medical Device Reporting regulations in addition to QSR violations.

Click here for FDA's Warning Letters homepage (scroll down for listing of recently posted Warning Letters).

The Office of Prescription Drug Promotion ("OPDP") did not issue any warning letters since the last Update.

Click here for a complete listing of 2014 OPDP Warning Letters.

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