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Quality Control & Compliance

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Compliance Corner: 2 FDA Compliance Branch Heads Talk Regulatory Meetings – And What You Can Expect

US FDA Compliance Branch directors Gina Brackett and Melissa Michurski shed light on the agency's use of regulatory meetings. The FDA has been pulling enforcement punches in recent years, relying more on holding the face-to-face meetings than sending warning letters.

Compliance Corner FDA Compliance
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Latest From Quality Control

Warning Letter Roundup & Recap – 21 August 2019

A maker of in vitro diagnostics was dinged for premarket, quality systems, Medical Device Reporting and corrections & removals violations. It's just one of two device-related warning letters released by the US FDA this week.

Device Warning Letters FDA

Warning Letter Roundup & Recap – 13 August 2019

A maker of medical equipment, health-care supplies, and radiation products used for general and plastic surgery was cited for quality systems violations in the only device-related warning letter released by the US FDA this week.

Device Warning Letters FDA

EU And US Could Do More Together In Areas Of Medtech Approvals And Inspections

Will medical devices be among the next sectors to feature in the EU/US MRA? The EU has put forward suggestions on how to do device trade with the US through building regulatory co-operation.

Medical Device Europe

Compliance Corner: FDA Investigator Sees These 4 Common Sterilization Problems When Inspecting Facilities

Phil Pontikos, who is also the US agency's national device expert, explains how device-makers can avoid running afoul of the FDA's rules and expectations for sterilization activities.

Compliance Corner FDA

New Heartache For Abbott Implantable Cardiac Devices After Manufacturing Flaw Discovered

US regulators have notified the public about a recall of certain Abbott Ellipse implantable cardioverter defibrillators that are prone to electrical shorting due a manufacturing flaw. While the number of devices so far in the US is very small, the recall highlights continued issues with the ICDs since Abbott acquired them from St. Jude almost three years ago.

Regulation Safety

Warning Letter Close-Outs – July 2019

The US FDA released three device-related close-out letters in July.

Device Warning Letters FDA

Survey Finds 1/3 Of Device Firms Don't Measure The Cost Of Quality. Here's How A Case For Quality Initiative Might Help

A recent device industry survey shows that 33% of manufacturers are likely wasting money on quality efforts that are ineffective because they're not calculating the cost of quality. The survey comes under the auspices of a Case for Quality workgroup that is looking for best ways to engage leadership at device firms in quality activities. The group says it will use the survey results to inform its work as it pens a playbook of best practices for engaging leaders that will, among other things, stress the importance of knowing the cost of quality.

Quality Trends

Live Raccoons, Dead Possum Bring Consent Decree To Arkansas Distributor

A new consent decree requires an Arkansas distributor to stop selling medical devices and other FDA-regulated products after an inspection found rodents, insects and other animals at the company’s warehouses.

Enforcement Quality Control

Compliance Corner: These Are The 6 Top Process Validation Mistakes Made By Firms, According To An FDA Investigator

US FDA investigator Ben Dastoli sees medical device manufacturers making the same process validation mistakes over and over. Here are the top six validation problems he sees.

Compliance Corner FDA
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