The GMP Letter

CHICAGO — A recent trend of increasing FDA inspections and warning letters is continuing this year, as the agency has already issued 874 letters in fiscal 2011, compared with 673 last year, an FDA official says.

The FDA is implementing a new strategy to handle rising imports and an increasingly complex global supply chain, and it plans to begin collaborating with its foreign counterparts over the next 12 months, according to a new agency report.

Philips Medical Systems, a subsidiary of imaging devicemaker Philips Healthcare, was cited for various GMP shortfalls, including corrective and preventive action (CAPA) issues, in a recent FDA warning letter.

A warning letter the FDA sent to hematology in vitro diagnostic (IVD) manufacturer PointCare Technology Inc. notes a number of cGMP violations, including that the company failed to establish and maintain design validation procedures.

The FDA should launch a program to routinely and systematically assess device recall information, and use this to identify strategies for mitigating health risks presented by defective or unsafe devices, the Government Accountability Office (GAO) says.

A lengthy Form 483 to ventilator maker Newport Medical Instruments notes the company did not submit an MDR for a malfunction that would likely cause patient injury or death were the issue to recur.

An FDA inspection reveals that an Abbott Laboratories manufacturing site lacked adequate quality agreements for purchased products, according to a recent Form 483.

Device giant Beckman Coulter has been handed a Form 483 for observations related to corrective and preventive action (CAPA) procedures, process validation, incoming product acceptance procedures and device design validation.

CDRH is recommending manufacturers increase sampling of devices coming from Japan due to concerns that post-earthquake manufacturing conditions could impact the safety and effectiveness of the devices.

Syringe manufacturer Artsana was cited for various cGMP violations, including improper complaint handling procedures, in an FDA warning letter recently made available to the public.

Government prosecution of medical device-related cases will likely increase in the coming years, as less attention is placed on pharmaceuticals, a Justice Department attorney predicts.

Boston Scientific is conducting a Class I recall of its iCross catheters after several instances of the coronary imaging devices malfunctioning during intravascular ultrasound (IVUS) imaging.

The proportion of 510(k) vs. PMA devices behind high-risk recalls may have been misrepresented in a recent study criticizing CDRH’s clearance process, a new analysis says.

With no final rule in place for electronic medical device reports (eMDRs), some small devicemakers appear to be opting out of voluntarily switching over to electronic reporting early.

CDRH plans to cut back on domestic facility inspections in fiscal 2012 in an effort to ramp up its visits to foreign sites, an FDA official says.