Snug Seat looks to get back in saddle
MATTHEWS, N.C. – Snug Seat could soon resume distributing in the United States more than a dozen products manufactured in Denmark by R82.
The U.S. Food and Drug Administration (FDA) has scheduled a re-inspection of R82 in November to review changes the manufacturer has made since the agency inspected its facilities in 2010 and 2013, and found numerous violations.
“R82 is confident everything is in order and anticipates the FDA will release the detention within 45 to 50 days after the visit,” said Kirk MacKenzie, president of Snug Seat, which distributes seating, standing and walking aids for disabled children.
During previous inspections, the FDA found R82 violated six “good manufacturing requirements” of its quality system regulation, including failure to establish and maintain procedures for verifying or validating corrective and preventive action; failure to review and evaluate all complaints to determine whether an investigation is necessary; and failure to maintain device master records (DMRs).
MacKenzie characterized the violations this way: “There were no product problems or quality issues per see, but a lack of documentation needed for the products.”
The FDA has been refusing to allow 15 products—everything from the Cougar wheelchair to the Swan bath chair to the Rabbit mobile standing frame—to be imported.
The situation has taken its toll on Snug Seat—which has lost market share, especially for products like bath chairs—and its customers, MacKenzie acknowledges.
“We had a mother call us who, if she couldn’t get this device within 90 days, her child was going to need an operation,” he said. “It’s a specialized stander that no one else has. We managed to find a demo unit for the family to borrow.”
While R82 isn’t the only manufacturer to come under scrutiny by the FDA—it joins Invacare, for one—it’s unique in that the products in question are manufactured in Europe. Other companies that manufacture there should take heed, MacKenzie says.
“The requirements in Europe haven’t been that stringent, but they’re getting tighter,” he said. “It behooves those who manufacture in Europe to make sure their products have all the proper documentation.”