Acclarent, Inc. 3/20/13
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Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
San Francisco District
1431 harbor Bay Parkway
Alameda, CA 94501-7070
Telephone: (510) 337-6700
VIA UNITED PARCEL SERVICE
UIN # 394263
March 20, 2013
Bridget A. Ross
1525-B O’Brien Dr.
Menlo Park, CA 94025-1463
Dear Ms. Ross:
During an inspection of your firm located in Menlo Park, CA on January 29 through February 22, 2013, an investigator from the United States Food and Drug Administration (FDA) determined that your firm manufactures the Inspira AIR Balloon Dilation System, the Inspira AIR Balloon Catheter Inflation Device, and the Cyclops Multi-Angle Endoscope. 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 to affect the structure or any function of the body.
Our inspection also revealed that your firm’s Inspira AIR Balloon Dilation System devices 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 806 – Medical Devices; Reports of Corrections and Removals. Significant violations include, but are not limited to, the following:
Failure to report to FDA in writing a correction or removal, conducted to reduce a risk to health posed by a device as required by 21 CFR 806.10(a).
For example: Due to the potential for the balloon of the Inspira AIR Balloon Dilation System (all sizes) to not deflate or to deflate slowly, which could potentially result in airway obstruction, you removed the 18 x 40 mm size Inspira AIR Balloon Dilation System. The removal was reported to FDA and classified as a class I recall.
You made additional changes to the Instructions-For-Use distributed with all sizes of the device, and you updated physician training materials to include a warning of the potential airway obstruction. However, you failed to report to FDA in writing the field correction affecting all device size.
Your firm 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 FDA without further notice. These actions include, but are not limited to, seizure, injunction, and civil money penalties. Also, federal agencies may be advised of the issuance of 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 business days from the date you receive this letter of the specific steps your firm has taken to correct the noted violations, as well as an explanation of how your firm plans to prevent these violations, or similar violations, from occurring again. Include documentation of the corrections and/or corrective actions (including any systemic corrective actions) that your firm has taken. If your firm’s planned corrections and/or corrective actions will occur over time, please include a timetable for implementation of those activities. If corrections and/or corrective actions cannot be completed within fifteen business days, state the reason for the delay and the time within which these activities will be completed. Your firm’s response should be comprehensive and address all violations included in this Warning Letter.
Your firm’s response should be sent to: Lawton Lum, Director of Compliance, 1431 Harbor Bay Parkway, Alameda, CA 94502.
Refer to the Unique Identification Number 394263 when replying. If you have any questions about the contents of this letter, please contact: Sergio Chavez, Compliance Officer at (510) 337-6886 or (510)3376703 (fax).
Finally, you should know that this letter is not intended to be an all-inclusive list of the violations at your firm’s facility. It is your firm’s responsibility to ensure compliance with applicable laws and regulations administered by FDA. The specific violations noted in this letter and in the Inspectional Observations, FDA 483, issued at the close of the inspection may be symptomatic of serious problems in your firm’s manufacturing and quality management systems. Your firm should investigate and determine the causes of the violations, and take prompt actions to correct the violations and bring the products into compliance.
Acting District Director