Align Technology received a warning letter from the U.S. Food and Drug Administration (FDA) on November 18 following an onsite inspection of Align's corporate headquarters between June 29 and August 9, 2010, and is now working to inform the agency of the steps it has taken in response to the warning letter, the company announced.
The FDA inspection resulted in the issuance of a Form 483 Notice, which contained four observations pertaining to the company's Invisalign system.
The first stated that Align failed to file reports of "individual adverse events" that resulted in death or serious injury that could plausibly be caused by use of their product within 30 days of receiving them. In addition, Align failed to signal in a timely manner whether a malfunction caused the complaint and, if so, would harmful results come from a recurrence of such a malfunction, according to the FDA.
The last two observations mention two specific complaints. In one, adverse symptoms a patient experienced, including "swollen, irritated, and sore lips" ceased when use of Align's device discontinued. In the next, a patient suffered a "burning tongue sensation, sore throat, ulcerations in the mouth, and swollen lymph nodes." The FDA stated that Align was aware that their "device would contribute to death or serious injury if the event were to recur."
Possible outcomes for no response included civil money penalties, seizure, and/or injunction. However, Align submitted a written response to the notice on August 26, which fell within the FDA's 15-business day deadline, and an additional written response on November 8 that provided a full and complete update of the actions the company has taken and plans to take to fully address the observations.
On November 22, Align submitted a written response to the warning letter that included copies of documentation requested by the FDA. Align has requested a meeting with the FDA to ensure that its response fully addresses the issues contained in the warning letter.
"Compliance with FDA regulations is taken very seriously at Align, and this matter is receiving the highest priority within the company," said Roger E. George, Align Technology vice president and general counsel, in a press release. "It appears that at the time the FDA issued the warning letter, it may not have fully reviewed the actions Align has completed and plans to complete to address the observations contained in the Form 483 Notice. We believe our response of November 8, 2010, may have crossed in the mail with the FDA's warning letter, and we are working with the FDA to quickly resolve this matter with minimal impact on the company."
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