The FDA slapped AngioDynamics (NSDQ:ANGO) subsidiary Navilyst Medical Systems with a warning letter for selling some long-term-use catheters contaminated by hair and other foreign matter and for not properly addressing the issue, among other quality issues.
As many as 55 complaints came in between May 2012 and May 2014 alleging the presence of hair in catheter packing that was supposed to be sterile, the FDA said.
The federal watchdog agency also took issue with Navilyst for not launching a formal look into the allegations, even as the company asserted packages were visually inspected for that kind of problem, according to the warning letter. AngioDynamics in 2012 acquired Navilyst for about $372 million.
AngioDynamics president & CEO Joe DeVivo told MassDevice.com via email today that the company is working with the agency to address the issues.
“We have provided comprehensive responses and will continue to work to satisfy the FDA’s concerns. We feel that the issues cited by the agency are relatively narrow in scope and we are responding appropriately. We do not anticipate a material impact on our business," DeVivo wrote.
FDA inspectors allege in the Nov. 4 letter that Navilyst lacks sufficient quality control systems at its Marlborough, Mass., and Glens Falls, N.Y., facilities. The letter zeroed in on 3 products: the Vaxcel, Xcela and Biostable (BioFlo) peripherally inserted central catheters and their related equipment and packaging. Inspections took place from April 9 to May 28 in Marlborough and Feb. 24 to March 30 in Glens Falls.
Navilyst/AngioDynamics has 15 business days from receipt of the letter to address any corrective actions it has taken. The FDA could take regulatory action if it isn’t satisfied with the results.
In Marlborough, the FDA said it identified a number of quality violations, including a sub-par process to verify design specs for 1 of the Vaxcel catheters, two Xcela iterations and the Biostable catheter kits. Regulators faulted the company for not verifying that the packaging configurations are effective in protecting the catheter kits from damage and maintaining sterility after sale and aging.
The FDA also knocked Navilyst for not having enough processes in place to make sure the products aged safely on the shelf. The company violated its own guidelines for shelf life quality control, as well as its specifications regarding humidity controls for how the products are kept and stored, according to the letter.
In Glens Falls, the FDA cited Navilyst for similar violations regarding quality control procedures. Regulators found fault in areas including the company’s lack of procedures for verifying that its catheters were manufactured according to device design. Although Navilyst took a number of corrective actions, the FDA said either that it didn’t have enough information to deem those sufficient or that they were insufficient.