FDA also warns GF, Merits
YARMOUTH, Maine - It looks like the U.S. Food and Drug Administration (FDA) has its eyes on more than just Invacare.
The FDA sent warning letters to GF Health Products/d.b.a Basic American Metal Products and Merits Health Products in December and November, respectively. In the case of GF, the letter was the culmination of an investigation at its bed manufacturing facility in Fond du Lac, Wis., from Aug. 29 to Sept. 23.
"There's no question there's increased emphasis on DME manufacturers right now," said Ken Spett, president and CEO at GF. "We've been inspected before in different locations, but we've never had an inspection lasting three weeks--ever. We didn't think there was that much to look through."
Invacare and the FDA are still trying to negotiate an agreement to address concerns with the company's corporate headquarters and wheelchair manufacturing facility in Elyria, Ohio, according to Lara Mahoney, director of investor relations and corporate communications. In December, Invacare announced the FDA proposed it suspend certain operations at the facilities.
The letter to GF cited 10 violations, including failing to adequately investigate, document and close complaints within the required 30-day timeframe. Since it received the letter, GF has been putting "corrective actions" in place and has been updating the agency on its progress, Spett says. "Eventually, everything in the letter will be dealt with," he said.
The letter states GF's response to the violations has been adequate, with one exception: Failure to report a correction or removal conducted to reduce a risk to health posed by a device. GF has sent another response to the FDA and is waiting to hear back, Spett says.
Additionally, the letter states that a follow-up inspection will be necessary. That's fine by Spett.
"We welcome it," he said. "We spend a lot of money on our internal audits and our third-party audits. The FDA's investigation is free and, in the long run, will help to correct some things."
Repeated calls and emails to execs at Merits Health were not returned.
The letter to Merits Health details the results of an investigation at its manufacturing facility in Taichung, Taiwan, from July 11 to July 14. It cites eight violations, including failure to establish and maintain adequate procedures for implementing corrective and preventative action; and failure to establish and maintain adequate procedures to ensure each production run meets acceptance criteria.
The letter states Merits Health's response to the violations has not been adequate. As a result, the agency may take steps to deny the company's power wheelchairs and scooters, and stair chair lifts--in a process known as "detention without physical examination"--until violations are corrected.