Featured Product
This Week in Quality Digest Live
FDA Compliance Features
Dirk Dusharme @ Quality Digest
Companies say they plan to pull some or all of their devices
Dirk Dusharme @ Quality Digest
First step, migrate your QMS to a cloud-based electronic quality management system
Jill Roberts
Another way to know what’s too old to eat
Patricia Santos-Serrao
Four pharma quality trends
Del Williams
Preventing damage caused by large, suspended particles

More Features

FDA Compliance News
Showcasing tech, solutions, and services at Gulfood Manufacturing 2022
Easy, reliable leak testing with methylene blue
Now is not the time to skip critical factory audits and supply chain assessments
Google Docs collaboration, more efficient management of quality deviations
Delivers time, cost, and efficiency savings while streamlining compliance activity
First trial module of learning tool focuses on ISO 9001 and is available now
Free education source for global medical device community
Good quality is adding an average of 11 percent to organizations’ revenue growth
Further enhances change management capabilities

More News

Michael Causey

FDA Compliance

FDA Eases Up a Bit on Enforcement Gas Pedal

Fewer warning letters, but CAPAs continue to garner the most citations

Published: Thursday, November 19, 2015 - 12:52

Medical device warning letters and domestic inspections continue to show a slow decline, according to a new report issued by the U.S. Food and Drug Administration (FDA). The number of medical device-related warning letters dipped to 121 during calendar year (CY) 2014, compared to 144 during the prior reporting period.

For the fifth year in a row, U.S. inspections declined. They dropped to 1,619 in 2014, compared to 2011’s 1,931, and 2013’s 1,741. However, at least one thing remained constant: Production and process controls, and corrective and preventive actions (CAPA) continue to be the most frequently cited quality management system subsystems.

More than half of CAPA observations were related to 21 CFR 820.100(a) and 21 CFR 820.198(a), and a bit more than 10 percent cited 21 CFR 820.90(a).

On the other hand, foreign inspections posted their highest number in years, with 594 in 2014. That’s way up from 210 in 2008 and 460 in 2013. The agency said it’s been working to increase its foreign inspection stats as foreign manufacturer inventory has grown. China was the biggest target (190) in 2014, followed by Germany (72), Japan (37), and Taiwan (29). It’s a bit of a surprise not to find India on the list, but that country’s regulators have something of a reputation for blatantly favoring local firms over “invaders” from outside its borders. There could be a connection.

Casting a wider net, the FDA reported interesting stats based on some 14,271 domestic and foreign inspections conducted between 2009 and 2015. Domestically, manufacturers got off the hook with “no action” more than half of the time. At the same time, the FDA did demand action 8 percent of the time. The numbers were a bit harsher when it came to foreign inspections: 42 percent wriggled free with no action, and 15 percent got the opposite directive.

The report also reveals that the FDA issued 1,106 Form 483s covering 2,213 QSIT inspections during 2014. It issued 3,740 483s, citing quality system regulation deficiencies over the same time period.

First published Nov. 5, 2015, on the AssurXblog.

Discuss

About The Author

Michael Causey’s picture

Michael Causey

James Michael Causey’s been a journalist since he started his own neighborhood newspaper in the 1970s. In addition to quizzing FDA officials for the past 10+ years, he’s also interviewed political satirist Art Buchwald, FCC Chairman Reed Hundt, SEC Chairwoman Mary Schapiro, and is the past president of the Washington Independent Writers. Causey is the editor and publisher of eDataIntegrityReport.com and is a contributing writer on the AssurXblog.