FDA update: Reviews, inspections and audits

Friday, October 5, 2012

YARMOUTH, Maine – There’s a light at the end of the tunnel for HME manufacturers that have spent the better part of the past two years wrangling with the Food and Drug Administration (FDA).

After an “official documents review” this summer, Merits Health in September received a letter from the FDA stating its “corrections and corrective actions…appear adequate,” according to Jonathan Cheng, vice president.

“Merits is now confirmed to be inspected in early November,” he said. “We are gratified to see some progress on this case, and we are still working hard to get this resolved.”

Merits received a warning letter in November 2011 citing eight violations at its manufacturing facility in Taiwan. The manufacturer has blamed a backlog at the FDA for delays in closing its case.

At GF Health Products, the FDA has approved all corrections following an inspection this summer, according to Ken Spett. The manufacturer had been waiting for the agency to approve corrective actions for one last violation.

“We’ve been approved with monthly reports to the FDA,” said Spett, president and CEO of GF.

GF received a warning letter in December 2011 citing 10 violations. Earlier this year, the manufacturer added two more employees to its quality control team, Spett said.

“We’re going to keep on improving all procedural items,” he said.

At Invacare, the plan remains to conduct a third-party audit in the fourth quarter. The results of the audit will be shared with Invacare and the FDA simultaneously, according to Lara Mahoney, director of investor relations and corporate communications.

“They could say, ‘You passed the third-party audit, we’ll move on,’ but it’s more likely that they’ll then come in and do their own audit,” she said.

At the same time, Invacare is still trying to negotiate a consent decree, or agreement, with the FDA concerning the suspension of certain operations at its corporate and wheelchair manufacturing facilities in Elyria, Ohio, Mahoney said.

“The negotiations are still ongoing,” she said. “I would imagine the audit would help with the consent decree, because it will show all the work we’ve done and that we’re in compliance.”