NEW YORK (MainStreet) – The Food and Drug Administration has sent a warning letter to Align Technology, Inc. after it was revealed that the company failed to notify the agency of several allergic reactions to their Invisalign braces.
In a letter dated Nov. 17, the FDA took the company to task for “Failure to submit reports of individual adverse events no later than 30 calendar days after the day that you receive or otherwise become aware of information, from any source, that reasonably suggests that a device that you market may have caused or contributed to a death or serious injury.”
The agency apparently learned of multiple allergic reactions to the Invisalign system during a mid-summer inspection of the company’s facilities, some of which were considered life-threatening. In one case, a patient “experienced a burning tongue sensation, sore throat, ulcerations in the mouth and swollen lymph nodes,” the letter said. The company’s failure to report these incidents in a timely manner constituted a violation of Medical Device Reporting regulations.
In addition to the failure to disclose these incidents in a timely manner, the FDA also slammed the company for failing to respond to the concerns raised during the inspection. In a press release, the company insisted that they’d provided the FDA with a written response on Nov. 8. “We believe our response of November 8, 2010 may have crossed in the mail with the FDA's Warning Letter,” said the company.
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