Inspections, Compliance, Enforcement, and Criminal Investigations
Dialysis Dimensions Inc. 02-Oct-07
Department of Health and Human Services
Public Health Service
New Orleans District
October 2, 2007
WARNING LETTER NO. 2008-NOL-01
Mr. Michael J. Peterson
CEO and President
Dialysis Dimensions Inc.
2003 Blair Boulevard
Nashville, Tennessee 37212
Dear Mr. Peterson:
During an inspection of your firm, located in Nashville, Tennessee, on May 2-3, 7-9, 15 and 17, 2007, investigators from the United States Food and Drug Administration (FDA) determined your firm manufactures the BiCarb Mixing System, the AquaDuct® Fluid Delivery Networks,and the Water Vault Cube. Under Section 201(h) of the Federal Food, Drug, and Cosmetic Act (the Act) [21 United States Code (USC) 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.
This inspection revealed these devices are adulterated within the meaning of Section 501(h) of the Act [21 USC 351(h)], as 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 (CGMP) requirements of the Quality System (QS) regulation found in Title 21, Code of Federal Regulations, Part 820 (21 CFR 820). These violations include, but are not limited to, the following:
1. Failure to have management with executive responsibility to ensure the quality policy has been fully implemented and maintained [21 CFR 820.20(a)]. Admittedly, you lack a Quality Plan and a management representative and have continued to operate since 2004.
2. Failure to properly implement, maintain, and follow complaint procedures [21 CFR 820.198(a), (a)(1), and (a)(3)]. You failed to follow your own procedures to investigate complaints received by your firm. Complaints received by e-mail are filed electronically instead of logging them into a hard copy paper system set to fully document and investigate complaints, as required by your written procedures.
3. Incidents representative of Medical Device Reporting reportable events were not properly considered complaints, and no Medical Device Reporting was seat to FDA [21 CFR 820.200(c)]. For example, the complaint from a client in [redacted] reported higher lowest achievable levels for endotoxin units on September 25, 2005, and the client expressed a concern for patient safety. No action was taken by your firm, and no Medical Device Reporting was reported to FDA.
4. Failure to validate your water purification systems for hemodialysis device [21 CFR 820.75(a) and (c)]. The pre-treatment water purification, fluid delivery, and heat disinfection systems have not been validated. Although you indicate you follow AAMI standards for the fluid delivery system, our inspection did not support your claim. AAMI recommends one continuous loop, but you developed a [redacted] fluid delivery system with no data to support your claims of flow rates and acid levels.
5. Failure to validate your software used for fluid delivery and heat disinfection in your water purification systems [21 CFR 820.70(i) and (b)]. For example, implementations of remote changes in operating parameters change the output of the system. These types of changes require re-validation of the system. You failed to follow your own procedure for change controls when critical limits were changed to suit a client's needs.
6. Failure to implement procedures; document and verify; and, validate corrective and preventive actions (CAPA) [21 CFR 820.100(a),(b),(a)(1), and (a)(4)]. Although your firm has implemented a procedure for "Operations Quality Audit," you have not implemented a full CAPA system. For example, investigators reviewed 40 complaints received by your firm since the previous inspection on June 16-17, 2004. The review found approximately 43% of the complaints relate to the heat disinfection system. There was no indication complaint data was trended or fully investigated.
7. Failure to establish and maintain adequate design controls for your device to ensure specified design requirements are met [21 CFR 820.30]. For example, design changes are implemented routinely to accommodate each client, but these changes are not validated. Design transfer is not addressed, and design history files do not document installation testing. No risk analysis has been performed to identify process parameters are controlled by design input and output requirements.
8. Failure to document component control numbers in the Device History Records (DHR) [21 CFR 820.65]. Although you have a record of these numbers, they are not included in the specific DHR.
9. Failure to establish and maintain purchasing control procedures [21CFR 820.50]. There are no incoming component specifications for acceptance and no supplier quality agreements. These failures have led to a device failure. In this instance, a third party manufactured a [redacted] which ultimately failed. No notification of specification changes was received by your firm.
Our inspection also revealed your devices are misbranded under Section 502(t)(2) of the Act [21 USC 352(t)(2)], as your firm failed or refused to furnish material or information respecting the device, as required by Section 519 of the Act [21 USC 360i] and 21 CFR 803 - Medical Device Reporting regulation. Significant deviations include, but are not limited to, the following:
1. Failure to develop and implement written Medical Device Reporting procedures, as required by 21 CFR 803.17. For example, written Medical Device Reporting procedures could not be produced when requested during the inspection.
Our inspection also revealed the BiCarb Mixing System with heat disinfection and the AquaDuct® Fluid Delivery Network are adulterated under Section 501(f)(1)(B) of the Act [21 USC 351(f)(1)(B)], because you do not have an approved application for premarket approval (PMA) in effect pursuant to Section 515(a) of the Act [21 USC 360e(a)] or an approved application for an investigational device exemption under Section 520(g) of the Act [21 USC 360j(g)]. The devices also are misbranded under Section 502(o) of the Act [21 USC 352(o)], because you did not notify the FDA of your intent to introduce the devices into commercial distribution, as required by Section 510(k) of the Act [21 USC 360(k)]. For a device requiring PMA, the notification required by Section 510(k) of the Act [21 USC 360(k)] is deemed satisfied when a PMA is pending before the FDA, 21 CFR 807.81(b). The kind of information you need to submit in order to obtain approval or clearance for your devices is described on the FDA Internet at http://www.fda.gov/cdrh/devadvice/3122.html. The FDA will evaluate the information you submit and evaluate whether your products may be legally marketed.
The above deficiencies should not be construed as an all-inclusive list of violations which may exist at your facility, and they may not be limited to the above-cited products. It is your responsibility to ensure your facility is operating in full compliance with all applicable requirements of the Act and the implementing regulations.
You should take prompt action to correct these violations addressed in this letter. Failure to promptly correct these violations may result in regulatory action without further notice, including seizure, injunction, and/or civil money penalties. Federal agencies are advised of the issuance of all warning letters about devices so they may take this information into account when considering the award of contracts. Additionally, PMA applications for Class III devices to which the QS regulation deviations 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 (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.
Please address your reply to Ms. Kari L. Batey, Compliance Officer, at the above address. If you have any questions about the content of this letter, please contact Ms. Batey at 615-366-7808 or by facsimile at 615-366-7812.
H. Tyler Thornburg
New Orleans District
Enclosure: Form FDA 483, dated May 17, 2007