Featured Product
This Week in Quality Digest Live
FDA Compliance Features
Dario Lirio
Modernization is critical to enhance patient experience and boost clinical trial productivity
Alexander Khomich
Healthcare software opens up opportunities for clinics in both management and patient care
Gary Shorter
Pharma needs to adapt and evolve with the changing environment of life science data
Etienne Nichols
Quality management system regulation explained
The short answer: Standard weights, rigorous procedures, and state inspectors ensure measurements are fair and accurate

More Features

FDA Compliance News
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
Creates adaptive system for managing product development and post-market quality for devices with software elements
VQIP allows for expedited review and importation for approved applicants that demonstrate safe supply chains
An invite from Alcon Laboratories
Intended to harmonize domestic and international requirements
Pharma quality teams will have performance-oriented objectives as well as regulatory compliance goals

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 - 13:52

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.


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.