March 2013 --
Keith C. Valentine
President and Chief Operating Officer
7475 Lusk Blvd.
San Diego, California 92121
Dear Mr. Valentine:
During an inspection of your firm located in San Diego, California, on October 29, 2012, through November 2, 2012, an investigator from the United States Food and Drug Administration (FDA) determined that your firm manufactures the Affix Spinous Process Plate System. 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 revealed that the Affix Spinous Process Plate Systemis adulterated under section 501(f)(1)(B) of the Act, 21 U.S.C. § 351(f)(1)(B), because your firm does not have an approved application for premarket approval (PMA) in effect pursuant to section 515(a) of the Act, 21 U.S.C. § 360e(a), or an approved application for an investigational device exemption under section 520(g) of the Act, 21 U.S.C. § 360j(g). The device is also misbranded under section 502(o) the Act, 21 U.S.C. § 352(o), because your firm did not notify the agency of its intent to introduce the device into commercial distribution, as required by section 510(k) of the Act, 21 U.S.C. § 360(k). For a device requiring premarket approval, the notification required by section 510(k) is deemed satisfied when a PMA is pending before the agency. [21 CFR 807.81(b)] The kind of information that your firm needs to submit in order to obtain approval or clearance for the device is described on the Internet at http://www.fda.gov/MedicalDevices/Device RegulationandGuidance/HowtoMarketYourDevice/default.htm. The FDA will evaluate the information that your firm submits and decide whether the product may be legally marketed.
For example, the “ILIF Surgical Technique” indicates that the Affix plate may be used “as an adjunct to interbody fusion (XLIF®, ALIF, PLIF, and TLIF.)” Although your firm has multiple 510(k)s cleared for this device, none of them include the use of the Affix plate with only an intervertebral body fusion device. This constitutes a new intended use and a new 510(k) is required in accordance with 21 CFR 807.81(a)(3)(ii).
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: William S. Vitale, DMD, Compliance Officer, U.S. Food and Drug Administration, Los Angeles District Office, 19701 Fairchild, Irvine, California 92612. Refer to the Unique Identification Number 392911 when replying. If you have any questions about the contents of this letter, please contact: William S. Vitale, DMD at (949) 608-2919, (949) 608-4415 (fax) or, via e-mail to Bill.Vitale@fda.hhs.gov.
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.
Alonza E. Cruse, Director
Los Angeles District
Patrick Kennelly, Acting Chief
California Department of Public Health
Food and Drug Branch
PO Box 997435
1500 Capitol Avenue, MS-7602
Sacramento, CA 95899-7413