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FDA Compliance

FDA Warning Letters Target Weak CAPA Programs Globally

What to know—and avoid

Published: Wednesday, November 30, 2016 - 13:06

Life sciences companies around the world should make sure their corrective and preventive action (CAPA) plans are in good shape before a Food and Drug Administration (FDA) inspector comes calling. Looking at a deep pool of letters issued this year domestically and internationally, it’s clear the agency will focus like a laser on CAPA.

The good news is that taking a look at FDA inspection patterns can help medical device manufacturers proactively assess and improve their own programs.

In a June 30, 2016, warning letter, the agency zeroed in on the CAPA program at TriMed, a manufacturer of implantable bone fixation systems based in Santa Clarita, California. Long story short: It didn’t like what it found. Here’s why:

Data integrity questioned

The company failed to include a requirement to analyze sources of quality data in customer complaints documented in an error log. Making matters more complicated, the firm failed to provide a timeline for when it would make these and other CAPA fixes, according to the FDA. It’s widely known that the FDA is far more forgiving if a firm adequately addresses its shortcomings out of the gate. Back-and-forth correspondence with the FDA isn’t generally a good sign.

In Montreal, Canada, the FDA didn’t like some of the CAPA program at Zimmer Biometric Holding. The firm manufactures the iAssist Knee System, Zimmer PSI Shoulder System, Zimmer PSI Knee System, and the Navitrack System. Each is classified as a medical device subject to FDA regulations.

Specifically, the FDA hit the firm for failing to establish a procedure to describe how data will be analyzed to detect recurring quality problems. The agency also cited CAPA shortcomings including failure to demonstrate a procedure to include requirements to verify or validate the actions. There’s an old FDA maxim, “If it isn’t documented, it didn’t happen.” Zimmerman apparently missed that point and is paying a price.

Documentation demanded

The FDA also cited Zimmerman’s alleged shortcomings in sharing any findings of product quality issues with the folks onsite responsible for making sure that doesn’t happen again. Finally, the FDA said the company didn’t demonstrate that it had any process in place that ensured management had a final review of any CAPA program improvements.

Failure to effectively guarantee data quality was also a theme when the FDA inspected General Medical Co.  in Pasadena, California. There, the manufacturer of iontophoresis devices designed to control hyperhidrosis in the underarms, hands, and feet, was accused of failing to come up with a plan to make sure customers were aware of the potential risks of using the product. The FDA also wrote the company up for failing to analyze complaints for any patterns or develop a CAPA process that ensured potential users understood the dangers.

Data analysis and documentation shortcomings was also featured prominently in another June 2016 letter the FDA issued to device maker 86 Harriet Avenue Corp., doing business as General Devices in Ridgefield, New Jersey. The company’s existing CAPA program did not require that data sources be analyzed to look for product problems or for the company to dig deeper to find the root cause of problems. For example, the company failed to properly investigate notifications that its product’s screen had no display, went black after a few seconds, or did not turn on during installation.

FDA also challenged a New Jersey maker of an antibacterial envelope drug with failing to make sure it’s CAPA program included ways to identify and ensure that devices it is making or has already sold don’t have possible nonperformance issues. In some cases, TYRX Inc. closed its CAPA investigations too early, the FDA said in the June warning letter.

Closing CAPA investigations prematurely was also an issue when FDA inspectors traveled to Córdoba, Argentina, and hit F.P. Rubinstein Y CIA SRL over a series of alleged CAPA shortcomings. The FDA has gone back and forth with the manufacturer of laser-powered surgical instruments since late 2014. In a May 2016 warning letter, the agency cited a number of CAPA problems, including closing CAPA records without demonstrating that the company had performed required validation and documentation.

Finally, FDA inspectors in China accused Master & Frank Enterprises of significant shortcomings in its risk analysis work. The firm, based in Guangdong, China, manufactures surgical gowns and drapes. The FDA also zeroed in on the company’s CAPA program, which threatened the company’s ability to produce safe products that met the performance specifications it was designed for.

Avoid CAPA citations

Weak CAPA programs will continue to be a recurring theme in FDA warning letters. No matter where an issue arises, automated CAPA software like AssurX can isolate an issue as its arises and assist in swiftly managing its resolution.

Interested in learning industry best practices to avoid being cited? Quality professionals at life-science organizations are invited to review an automated CAPA webcast.

First published Nov. 8, 2016, on the AssurX blog.


About The Author

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AssurX Inc. develops quality management and regulatory compliance software solutions to help companies in any industry exceed quality expectations, ensure compliance, manage risks, and better govern their enterprise. AssurX solutions securely handle manufacturing defects, complaints, change control, regulatory compliance, supplier quality, audits, risk, corrective and preventive actions, and more.