BioHorizons says action taken on FDA violations

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March 23, 2005
CHARLES R. McCAULEY
The Birmingham News
BioHorizons Implant Systems Inc. said it is taking "corrective actions" on violations cited by federal inspectors who visited the Birmingham dental device maker's operations.
Issues raised in a Food and Drug Administration warning letter were administrative in nature and "did not question the safety and efficacy of our products," said Chief Executive R. Steven Boggan.
"We disagreed with several of the observations that they raised in the warning letter," Boggan said Tuesday. Nevertheless, he added, "we have taken corrective actions to address all of the issues raised" in the Dec. 27 letter from the FDA.
BioHorizons executives have since met with officials at FDA's New Orleans district office about the steps the company has taken.
"In subsequent communications with BioHorizons, the FDA district office indicated that they were pleased with our response to the warning letter and they will audit us at a future date to verify the corrective actions that we provided to them in writing," Boggan said.
Didn't respond:
He said BioHorizons also is audited every year by European and Canadian regulatory agencies - where it has operations - and multiple times by the FDA. "We have no history of regulatory noncompliance that suggests the representations made in the warning letter are typical or continuing in the company."
The FDA's concerns are based on inspections Oct. 26-29 and Nov. 1-2 at BioHorizons' facility at Perimeter Park South. An FDA investigator, the letter says, determined that some of the company's practices didn't conform to manufacturing regulations for medical devices.
The letter says the company failed to:
Conduct regular internal audits, supplier and contractor evaluations, and management review meetings to ensure an adequate and effective quality system.
Keep device history records showing each batch of finished devices meets acceptance criteria before distribution.
Conduct investigations of complaints on possible failure of dental devices to meet specifications and to document why investigations weren't conducted.
"Specifically, our investigator collected (redacted) complaints involving the Maestro Implant dated between July and September 2004," the FDA letter to BioHorizons says. Records show "that no one conducted an investigation in response to these complaints, nor did anyone record any reason explaining why no investigation was conducted."
The letter further claims BioHorizons failed to conduct and document adequate corrective and preventive steps regarding complaints on its products. "Because of this, you may fail to detect and prevent recurring quality problems, which may be causing the device failures identified in the complaints," the letter states.
Boggan said the "success rate" of the company's implant systems exceed those in the published industry literature. "Moreover, we have never had an implant fracture, whereas our competition has had reports of implant fractures," he said.
Reinspection expected:
He said three BioHorizons competitors, including market leader Nobel Biocare, also received FDA warning letters.
Efforts to reach the FDA district office for comment were unsuccessful.
"I imagine at some point in the latter half of this year, the FDA will inspect our facilities again," Boggan said.
Dental implants made by BioHorizons, founded in 1994, are used as replacements for missing teeth. The company also markets surgical instruments and equipment.