| Public Health Service Food and Drug Administration |
San Francisco District |
Department of Health and Human Services
WARNING LETTER
VIA UPS
November 17, 2010
Mr. Thomas M. Prescott
President and Chief Executive Officer
Align Technology, Inc.
2560 Orchard Parkway
San Jose, California 95131
Dear Mr. Prescott:
During an inspection of your firm located in San Jose, California on June 29, 2010, through August 9, 2010, an investigator from the United States Food and Drug Administration (FDA) determined that your firm manufactures the Invisalign System, including orthodontic devices and appliances. Under section 201(h) of the Federal Food, Drug, and Cosmetic Act (the Act), 21 U.S.C. 321(h), these products are devices because they are intended for use in the diagnosis of disease or other conditions or in the cure, mitigation, treatment, or prevention of disease, or are intended to affect the structure or function of the body.
Our inspection revealed that your Invisalign System, including orthodontic devices and appliances are misbranded under section 502(t)(2) of the Act, 21 U.S.C. 352(t)(2), in that your firm failed or refused to furnish material or information respecting the device that is required by or under section 519 of the Act, 21 U.S.c. 360i, and 21 CFR Part 803 - Medical Device Reporting (MDR) regulation. We received a response from Mr. David Kolesar, Director, Regulatory Affairs and Quality Systems dated August 26, 2010, concerning our investigator's observations noted on the Form FDA 483, List of lnspectional Observations that was issued to you. We address this response below, in relation to each of the noted violations. These violations include, but are not limited to, the following:
1. 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, as required by 21 CFR 803.50(a)(1). For example, Complaint Identification Number (b)(4) documents a patient received steroids for the treatment of adverse events which occurred subsequent to the use of your Invisalign System. You became aware on March 17, 2008, of this event in which the device caused or contributed to the injuries of swelling that could be life threatening.
We have reviewed your response and have concluded that we cannot determine the adequacy at this time because your firm has not provided adequate documented evidence of written implemented corrections and corrective actions taken on this deficiency observed during the inspection. Specifically, your firm did not provide documentation of your revised standard operating procedures (SOPs), and revised forms.
2. 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 has malfunctioned and this device or a similar device that you market would be likely to cause or contribute to a death or serious injury, if the malfunction were to recur, as required by 21 CFR 803.50(a)(2). For example:
a. Complaint Identification Number (b)(4), received on November 2, 2007, documents a patient experienced "swollen, irritated and sore lips and additionally her gingival is also swollen". You have evidence from complaints received and filed as MDRs prior to this event that similar incidents required hospitalization. You also have documentation that the patient discontinued the use of the device to avoid further risk of further adverse events.
b. Complaint Identification Number (b)(4), received on May 11, 2010, documents that a patient experienced a burning tongue sensation, sore throat, ulcerations in the mouth and swollen lymph nodes. Based on previous events documented by Align Technology, Inc., your firm has knowledge that this device would be likely to cause or contribute to a death or serious injury if the event were to recur.
We have reviewed your response and have concluded that we cannot determine the adequacy at this time because your firm has not provided adequate documented evidence of written implemented corrections and corrective actions taken on this deficiency observed during the inspection. Specifically, your firm did not provide documentation of your revised standard operating procedures (SOPs), and revised forms.
You should take prompt action to correct the violations addressed in this letter. Failure to promptly correct these violations may result in regulatory action being initiated by the Food and Drug Administration without further notice. These actions include, but are not limited to, seizure, injunction, and/or civil money penalties. Also, federal agencies are advised of the issuance of all Warning Letters about devices so that they may take this information into account when considering the award of contracts.
Please notify this office in writing within fifteen (15) working days from the date you receive this letter of the specific steps you have taken to correct the noted violations, including an explanation of how you plan to prevent these violations, or similar violations, from occurring again. Include documentation of the corrective action you have taken. If your planned corrections will occur over time, please include a timetable for implementation of those corrections. If corrective action cannot be completed within 15 working days, state the reason for the delay and the time within which the corrections will be completed.
Your response should be sent to: Mr. Russell A. Campbell, Compliance Officer, San Francisco District, U.S. Food and Drug Administration, 1431 Harbor Bay Parkway, Alameda, California 94502. If you have any questions about the content of this letter, please contact Mr. Campbell at (510) 337-6861.
Finally, you should know that this letter is not intended to be an all-inclusive list of the violations at your facility. It is your responsibility to ensure compliance with applicable laws and regulations administered by FDA. The specific violations noted in this letter and in the Inspectional Observations, Form FDA 483 (FDA 483), issued at the closeout of the inspection may be symptomatic of serious problems in your firm's manufacturing and quality assurance systems. You should investigate and determine the causes of the violations, and take prompt actions to correct the violations and to bring your products into compliance.
Sincerely yours,
/s/
Barbara J. Cassens
District Director
San Francisco District
U.S. Food and Drug Administration
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