The Only Vote That Counts: FDA 483 Round-Up
Pollsters, prognosticators and pundits love to obsess over the polls before Election Day. But as wide political sages like to say, “The only poll that matters is the one on the day people actually vote.” Looking at the FDA isn’t much different. Lots of folks like to predict what the FDA will do, or try to glean trends from the often cryptic public statements FDA officials make at conferences or other gatherings. But the FDAs real “votes” are in the FDA 483s.
Reading through a recently-released crop of the agency’s medical device letters, it looks like the FDA is maintaining an interest in CAPA and employee training.
A letter issued after a month-long inspection that ended in May 2012, cited Cardiva Medical in Alameda, California for failing to adequately train its workers. Its Cardiva Catalyst is “designed to increase the comfort of the manual compression process and facilitate the body’s healing process,” according to the company’s website. It also allegedly failed to identify future training needs for its personnel, the 483 said..
Device manufactuer Coviden in Chicago was chastised after an inspection earlier in the year for CAPA shortcomings lacking “quality data sources that indicate the occurrence of high risk non-conformities.” The firm was also found wanting for failure to have a CAPA in place to “ensure that failure investigations are comprehensive.” Further, the FDA says it found a lack of a CAPA to “correct and prevent the issue of incomplete device history records.” Coviden manufactuers a number of products, including respiratory monitors and endomechanical products.
Other CAPA-related problems were found at Denver-based Sandhill Scientific. There, the FDA alleges the company lacked adequate an adequate CAPA program to address nonconformities and root causes. The company manufactures monitors aiding in acid reflux detection and a high resolution manometry system.
Arrow International in Parsippany, New Jersey, a Class II manufacturer of catheters, was hit with a 483 because “a validated process was not reviewed and evaluated when changes or process derivations occurred.”
We’ll keep tallying FDA’s real “votes” and an eye on real trends coming from the agency.