Inspections, Compliance, Enforcement, and Criminal Investigations
Alpha Medical Instruments, LLC 6/24/13
Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
|Los Angeles District|
Irvine, CA 92612-2506
VIA UNITED PARCEL SERVICE
June 24, 2013 WL# 43-13
Ms. Shigeko Tanaka
Alpha Medical Instruments, LLC.
23455 Madero, Suite B
Mission Viejo, CA 92691
Dear Ms. Tanaka:
During an inspection of your firm located in Mission Viejo, California, on December 19, 2012, through January 11, 2013, an investigator from the United States Food and Drug Administration (FDA) determined that your firm manufactures angiographic balloon catheters and electrophysiology catheters. 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 electrophysiology catheters your firm commercially distributes to (b)(4) are 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 devices are 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/DeviceRegulationandGuidance/HowtoMarketYourDevice/default.htm. The FDA will evaluate the information that your firm submits and decide whether the product may be legally marketed.
The electrophysiology catheters your firm commercially distributes to (b)(4) are adulterated under section 801(e)(1) of the Act, 21 U.S.C. 381(e)(1). Under this provision, a device not approved for marketing in the United States may not be legally exported if it does not meet the requirements of section 801(e)(1) of the Act. Further information about the requirements of section 801(e) of the Act may be found on the internet at
Our December 19, 2012, through January 11, 2013 inspection revealed that your electrophysiology catheters are misbranded within the meaning of Section 502(a) of the Act [21 U.S.C. 352(a)], in that their labeling is false and misleading. Labeling affixed to the packaging states: “Manufactured in the U.S.A. for Alpha Medical Instruments LLC”. However, the inspection revealed these catheters are improperly declared upon entry to the United States.
This inspection also revealed that your devices are adulterated within the meaning of section 501(h) of the Act, 21 U.S.C. § 351(h), in that the methods used in, or the facilities or controls used for, their manufacture, packing, storage, or installation are not in conformity with the current good manufacturing practice requirements of the Quality System regulation found at Title 21, Code of Federal Regulations (CFR), Part 820.
We received a response dated January 25, 2013, concerning our investigator’s observations noted on the Form FDA 483 (FDA 483), List of Inspectional Observations, which was issued to your firm. We address your response below, in relation to the noted violation. Your violations include, but are not limited to, the following:
1.) Failure of management with executive responsibility to review the suitability and effectiveness of the quality system at defined intervals, as required by 21 CFR 820.20(c). Specifically, your management review procedures, Management Responsibility, QSOP-1016, Rev. B require management review meetings to be held annually. Management has not conducted a review of your quality system since December 15, 2009. Your response is inadequate. You stated you have had a management review meeting on January 17, 2013, but did not provide evidence such a meeting was held.
2.) Failure to perform quality audits at defined intervals to determine whether the quality system activities and results comply with quality system procedures, as required by 21 CFR 820.22. Your Internal Quality System Audit procedures, QSOP-1014, Rev. B require audits of your quality system to be conducted at least annually. You did not conduct an audit of your quality system in 2011 or 2012. Your response is inadequate. You stated you established a schedule for monthly audits to start in December, 2012, and continue through November, 2013. You did not provide an audit schedule or evidence these audits have begun.
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. Additionally, premarket approval applications for Class III devices to which the Quality System regulation violations are reasonably related will not be approved until the violations have been corrected. Requests for Certificates to Foreign Governments will not be granted until the violations related to the subject devices have been corrected.
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: Mr. Blake Bevill, Compliance Branch, Food and Drug Administration, 19701 Fairchild, Irvine, CA 92612-2506. Refer to the Unique Identification Number CMS case # 393025 when replying. If you have any questions about the content of this letter please contact: Dr. William Vitale at 949-608-2919.
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
Hugo Cornejo, Acting Chief
California Department of Public Health
Food and Drug Branch
1500 Capitol Avenue MS 7602
PO Box 997435
Sacramento, CA 95899-7435
Attn: FDA Correspondence