The GMP Letter

As the FDA continues to ramp up its compliance and enforcement efforts, devicemakers are spending a lot more time dealing with the agency and answering a growing number of questions.

Tougher enforcement, pediatric devices and global supply chain issues are among the FDA’s top priorities for the next five years as the agency seeks to advance initiatives implemented since Margaret Hamburg became commissioner.

Better coordination between the FDA’s overseas offices and their domestic counterparts, as well as long-term strategic planning, is needed to improve the role of those offices in the face of growing regulatory challenges, the Government Accountability Office (GAO) reports.

Philips Medical Systems got a Form 483 noting 10 observations, including failure to conduct an internal audit of its quality system at the required interval.

AMO Puerto Rico Manufacturing’s investigations of consumer complaints do not always include a root cause determination, and corrective actions are not always identified, according to a recent Form 483.

Abbott Molecular’s Des Plaines, Ill., facility has received a Form 483 noting its corrective and preventive action procedure does not provide sufficient detail for conducting searches of exceptions, such as noncompliances, to determine the severity of the impact to product quality.

Devicemakers have a new tool to help them find suitable vendors — a CDRH database that provides information about device inspections from 2008 to the present.

Devicemakers should include their internet uniform resource locator (URL), when feasible, on their electronic product labels, according to a new guidance from the FDA.

Audits of device facilities should focus on the overall efficacy of the quality management system (QMS) rather than individual requirements, the Global Harmonization Task Force (GHTF) recommends in a new guideline on regulatory audit strategy.

In their rush to gain market share, devicemakers may be launching 510(k) devices without addressing some safety concerns, a CDRH official says in explaining an increase in Class I recalls.

Device companies with manufacturing facilities in Puerto Rico could be hit with a new tax next year that may have them rethinking their future on the island.

Axis Health Care received a warning letter because it lacked a number of written procedures and didn’t have clearance or approval for one of its devices.

A lack of device master records for its motorized scooters resulted in a warning letter for Amigo Mobility International.

Impact Instrumentation received a warning letter after an FDA inspection found its complaint-handling procedure does not require investigations into possible device failures.

The Standing Co., a manufacturer of stand-up wheelchairs, has received a warning letter noting its failure to evaluate certain wheel, brake and joystick controller suppliers for their ability to meet specifications.