FDA woes drag on for HME manufacturers

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Friday, June 8, 2012

ATLANTA and CAPE CORAL, Fla. – GF Health Products and Merits Health Products, which received warning letters late last year about violations at their manufacturing facilities, say the ball is in the U.S Food and Drug Administration’s (FDA’s) court.

At press time in June, GF was still trying to get the FDA to approve corrective actions for one last violation and Merits was trying to get the agency to re-inspect its facility in Taiwan.

“It is unusual for it to drag on this long,” said Ken Spett, president and CEO of GF. “But we’re moving forward; everything is progressing.”

The FDA sent a warning letter to GF in December (10 violations) and to Merits in November (eight violations). The letters were the results of inspections in August 2011 and July 2011, respectively.

GF expects to address all of the FDA’s concerns by the end of this summer, Spett said. It expects to conduct a second internal audit in July, he said.

“Then we’re almost certain to have a follow-up inspection by the FDA,” Spett said.

Merits is working with MDI Consultants, an independent agency, to help it address the FDA’s concerns. MDI has audited the manufacturer’s facility and processes in Taiwan, according to an emailed statement from Todd Aiazzone, projects coordinator at Merits.

“MDI is confident that the issues of corrective and preventative action have been addressed,” he wrote.

At least in Merits’ case, MDI believes a backlog at the FDA may be slowing the agency’s response time.

“MDI has been in meetings with the FDA several times to finalize this issue,” said Alan Schwartz, executive vice president at MDI. “The FDA response is that due to staff limitations there is a backlog for international inspections so they can’t commit to any certain timeframe, but they hope to be able to provide some answers soon.”

The latest on Invacare’s run-in with the FDA: The manufacturer reported to shareholders in April that it expects to engage a third party to audit its compliance in the fourth quarter of this year.