Inspections, Compliance, Enforcement, and Criminal Investigations
Dialysis Services, Inc. 15-Sep-06
Department of Health and Human Services
Public Health Service
New Orleans District
September 15, 2006
WARNING LETTER NO. 2006-NOL-15
Vincent T. Barker, President
Dialysis Services, Incorporated
130 Elder Drive
Springfield, TN 37172-5024
Dear Mr. Barker:
On July 10 - 12, 2006, a United States Food and Drug Administration (FDA) investigator inspected your facility, Dialysis Services, Incorporated, located at 130 Elder Drive, Springfield, Tennessee. The investigator determined your firm manufactures water purification systems for hemodialysis centers. 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. You may find guidance and more information regarding FDA regulations through links in FDA's internet home page at http://www.fda.gov and in the National Archives and Records Administration internet page at http://www.gpoaccess.gov/cfr/retrieve.html.
The inspection revealed these devices are adulterated within the meaning of Section 501(h) of the Act, 21 USC 351(h), because the methods used in, or 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 (CFR), Part 820. These violations include, but are not limited to, the following:
1. Failure to validate processes where the results of the processes cannot be fully verified by subsequent inspection and test, as required by 21 CFR 820.75(a). Specifically, your firm has not validated the water purification system disinfection and flushing processes recommended to your customers for the removal of physical, chemical, and microbiological contaminants.
2. Failure to establish, maintain, and implement procedures for verifying design output meets design input, as required by 21 CFR 820.30(f). Specifically, your firm has not established procedures to verify water purification systems are producing water product which meets defined acceptance criteria for chemical and microbiological contamination after installation.
3. Failure to establish, maintain, and implement procedures for validating the device design, and to document the results of the design validation, as required by 21 CFR 820.30(g). Specifically, your firm does not test product water while the water purification system is under actual use conditions to ensure the system conforms to the needs of the hemodialysis centers.
4. Failure to establish, maintain, and implement procedures for acceptance of incoming products, as required by 21 CFR 820.80(b). Specifically, your firm has not established procedures to ensure components, which are used to assemble water purification systems at hemodialysis centers, meet acceptance criteria .
5. Failure to establish, define, and implement procedures for acceptance of finished device production to ensure each production run, lot, or batch of finished devices meets acceptance criteria, as required by 21 CFR 820.80(d). Specifically, your firm has not established acceptance criteria or procedures to verify chemical and microbiological contaminants have been removed from the water product produced by water purification systems installed at hemodialysis centers.
We received a response from Mr. Mike S. Sterling, Vice President/COO, dated August 8, 2006, regarding the FDA investigator's observations noted on the July 12, 2006, Inspectional Observations, Form FDA 483 (FDA 483). Although this response contains updated written procedures, it does not establish your firm has implemented these procedures.
You 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/or civil money penalties. Also, 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, premarket approval 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 of receipt of 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 recurring. 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 actions cannot be completed within 15 working days, state the reason for the delay and the time within which corrections will be completed.
Your response should be directed to the U.S. Food and Drug Administration, Attention: Kimberly L. McMillan, Compliance Officer, 297 Plus Park Boulevard, Nashville, Tennessee 37217. If you have any questions about the content of this letter, please contact Ms. McMillan at (615) 781-5380, extension 138.
Finally, you should know this letter is not intended to be an all-inclusive list of the violations at your facility. It is your responsibility to ensure compliance with applicable laws and regulations administered by FDA. The specific violations noted in this letter and in the FDA-483 issued at the closeout of the inspection may be symptomatic of serious problems in your firm's manufacturing and quality assurance systems. You should investigate and determine the causes of the violations, and take prompt actions to correct the violations to bring your products into compliance.
Sandra S. Baxter
Acting District Director
New Orleans District