Inspections, Compliance, Enforcement, and Criminal Investigations

Advanced Renal Technologies Inc 5/8/14


Department of Health and Human Services logoDepartment of Health and Human Services

Public Health Service
Food and Drug Administration

Seattle District
Pacific Region
22215 26th Ave SE, Suite 210
Bothell, WA 98021

Telephone: 425-302-0340
FAX: 425-302-0402 


May 8, 2014
In reply refer to Warning Letter SEA 14-12
Michael D. Fulton
President and Managing Director
Advanced Renal Technologies, Inc.
40 Lake Bellevue Drive, Suite 100
Bellevue, Washington 98005
Dear Mr. Fulton:
During an inspection of your firm located in Bellevue, Washington, on March 24-31, 2014, and an additional visit on April 16, 2014, an investigator from the United States Food and Drug Administration (FDA) determined that your firm, as a specification developer, manufactures Citrasate, a dialysate for hemodialysis. 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.
This inspection revealed that these 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. These violations include, but are not limited to, the following:
1.    Failure to establish and maintain procedures to ensure that all purchased or otherwise received product and services conform to specified requirements, as required by 21 CFR 820.50. During the inspection you provided the ART Control of Suppliers Policy as your firm’s procedure covering the control of suppliers; however, you have not adequately implemented and documented this procedure. For example:
a.     Your procedure states that, “Frequent communication with any currently approved contract manufacturer (CM) will be maintained to determine that all production is going according to specifications.” However, your firm does not maintain documentation of communication with your contract manufacturers.
b.    Your procedure states that you will review all Establishment Inspection Reports issued by FDA for your contract manufacturers. However, your firm has not maintained documentation of these reviews. 
c.    Your procedure states that you will make inspection visits every (b)(4) years to your contract manufacturers and perform quality audit functions. However, you stated that it has been five years since you inspected (b)(4), and that you have not performed an inspection at (b)(4).
2.    Failure to establish and maintain the requirements, including quality requirements, that must be met by suppliers, contractors, and consultants, as required by 21 CFR 820.50(a). For example, you indicated that your firm does not have an established procedure that defines the quality requirements that must be met by your contract manufacturers. Additionally, your firm does not maintain documentation of your evaluation and selection of the contractors it uses to conduct the manufacturing and distribution of Citrasate.
3.    Failure to establish and maintain procedures for implementing corrective and preventive action (CAPA), as required by 21 CFR 820.100(a). For example, you indicated that your firm does not have CAPA procedures. 
4.    Failure to establish and maintain procedures to control the design of the device in order to ensure that specified design requirements are met, as required by 21 CFR 820.30(a).  For example, you indicated that your firm does not have procedures for design control. 
5.    Failure to establish procedures for quality audits and conduct such audits to assure that the quality system is in compliance with the established quality system requirements and to determine the effectiveness of the quality system, as required by 21 CFR 820.22. For example, no procedures for quality audits were available for review by the investigator. 
6.    Failure to establish and maintain procedures for finished device acceptance to ensure that each production run, lot, or batch of finished devices meets acceptance criteria, as required by 21 CFR 820.80(d). For example, you indicated that your firm does not have procedures covering finished device acceptance.  You also indicated that you do not review batch records and release documentation before lots are released for distribution.
7.    Failure to establish and maintain procedures for control and distribution of finished devices to ensure that only those devices approved for release are distributed and that purchase orders are reviewed to ensure that ambiguities and errors are resolved before devices are released for distribution, as required by 21 CFR 820.160(a). For example, you indicated your firm does not have procedures covering the control and distribution of Advanced Renal Technologies Inc.’s products.
8.    Failure to maintain device master records (DMRs) and ensure that each DMR is prepared and approved in accordance with 21 CFR 820.40, as required by 21 CFR 820.181. For example, you indicated that you maintain the formulations for Advanced Renal Technologies, Inc.’s devices, but that you do not maintain quality assurance procedures and production procedures as required by 21 CFR 820.181(b) and (c).
Under section 510 of the Act, 21 U.S.C. § 360, manufacturers of medical devices are required to annually register with the FDA. In September 2007, section 510 of the Act was amended by the Food and Drug Administration Amendments Act of 2007 (Pub. L. 110-85) to require domestic and foreign device establishments to submit their annual establishment registration and device listing information to FDA by electronic means [section 510(p) of the Act (21 U.S.C. § 360(p))] during the period beginning October 1 and ending December 31 of each year. Our records indicate that your firm has not listed Citrasate.
Therefore your firm’s device, Citrasate, is misbranded within the meaning of section 502(o) of the Act, 21 U.S.C. § 352(o), in that the device was not included in a list required by section 510(j) of the Act, 21 U.S.C. § 360(j).
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 (which must address systemic problems) 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.
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. 
Please submit your response to Jessica L. Kocian, Compliance Officer, 22215 26th Avenue SE, Suite 210, Bothell, Washington 98021. If you have questions regarding any issue in this letter, please contact Jessica Kocian at (425)-302-0444.
E. Mark Harris
Acting District Director
cc: Robin Callan, Vice President and Chief Operating Officer
      Advanced Renal Technologies, Inc.
      40 Lake Bellevue Drive, Suite 100
      Bellevue, Washington 98005

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