Navilyst Medical, a subsidiary of AngioDynamics, received an FDA warning letter for quality issues at two facilities, including the sale of sterile product that contained foreign matter such as hair.

The contamination problem, noted at the company’s Marlborough, Mass., facility, is “unacceptable regardless of your complaint rate,” the letter says. Navilyst also failed to open a corrective and preventive action to address complaints of hair found by end users.

According to the Nov. 4 letter posted recently online, Navilyst provided the investigator with a list of 55 complaints about hair in product packaging that it received between May 2012 and May 2014.

ut the company only conducted accelerated age testing on packaging for its Vaxcel peripherally inserted central catheter with pressure-activated safety valve, and not on the Xcela Power Injectable PICC, Xcela PICC with PASV and BioFlo (valve and unvalved) PICCs. 

The company’s rationale for using the data to support other PICCs failed to account for packaging changes and worse-case kit configurations in terms of density, the warning letter says. All of Navilyst’s products are long-term intravascular implantable catheters.

Additionally, the Xcela Power Injectable PICC with PASV was released for distribution before completion of a real-time aging study, although 20 catheters had fractures on their oversleeves after exposure to the temperature and humidity of accelerated aging conditions, the letter notes.

The FDA investigator determined that a required seal width sample failed to meet the company’s minimal predefined seal width specifications. The kits were released for distribution despite Navilyst not having identified the cause or repeated the testing. A later visual inspection found 95 of 550 kits had breached or completely open seals. A CAPA determined that the lid adhesive “could not withstand the temperature and humidity of the sterilization cycle and weakened seals, causing seal creep,” the warning letter says.

The Marlborough facility further failed to conduct or establish procedures for conducting quality audits. An internal audit of customer-related processes was scheduled for November 2013, but had not been conducted as of April 2014, the letter notes. 

In device manufacturing, sterile means precisely what it says: The total absence of viable microorganisms. Don’t get hit with a warning letter like this devicemaker did; purchase Manufacturing Sterile Products to Meet EU and FDA Guidelines today!