| Public Health Service Food and Drug Administration |
| Dallas District 4040 North Central Expressway Dallas, Texas 75204-3128 |
Department of Health and Human ServicesFebruary 24, 2010
Ref: 2010-DAL-WL-06
WARNING LETTER
CERTIFIED MAIL
RETURNED RECEIPT REQUESTED
Mr. Warren C. Mueller, President
Mueller Water Conditioning, Inc.
1500 Sherwood Forest Drive
Houston, Texas 77043-3899
Dear Mr. Mueller:
During an inspection of your firm located at the above-referenced address on September 30, 2009, October 1, 2,13 through 15,20,23, and 29, 2009, an investigator from the United States Food and Drug Administration (FDA or Agency) determined that your firm regenerates (manufactures) mixed-bed deionization (D1) tanks and carbon tanks that are used to provide treated water for use in 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 are intended to affect the structure or any function of the body.
This inspection 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 (CGMP) requirements of the Quality System (QS) regulations found at Title 21, Code of Federal Regulations (C.F.R), Part 820.
The violations include, but are not limited to, the following:
Quality System Violations
1. Failure to establish and maintain adequate control procedures that describe any process controls necessary to ensure that a device conforms to its specifications, as required by 21 C.F.R. § 820.70(a), and failure to review documents for adequacy and approve them prior to implementation, as required by 21 C.F.R. § 820.40(a). FDA 483 Item 1. Specifically:
Your firm has not established written manufacturing procedures for your Type I mixed-bed deionization (D1) resin and carbon tanks used for hemodialysis. Although your firm has obtained many manufacturing procedures (e.g. resin transfer, separation, regeneration, and mixing processes, purchase specifications, quality assurance testing, and labeling operations) from another manufacturer of similar devices and kept them in your "D1 Operations Manual, Volume I and II," your firm has never reviewed and revised these procedures to document your own manufacturing methods, equipment, and controls. Your firm indicated to our investigator that it used different resin and carbon specifications, manufacturing materials and equipment, and quality assurance testing and product labeling specifications.
2. Failure to establish and maintain adequate procedures for finished device acceptance to ensure that each production run, lot, or batch of finished devices meets acceptance criteria prior to releasing the devices for distribution, and for documenting their acceptance results, as required by 21 C.F.R. §§ 820.80(d) and (e). FDA 483 Item 2. Specifically:
Your firm has not established written procedures for testing, accepting or rejecting the new carbon resins and regenerated Type I D1 resins, and documenting their acceptance results. For example:
a. Although your firm tested several batches of the regenerated D1 resins and recorded their (b)(4) resistivity readings in the regeneration logs, your firm has not defined written acceptance criteria for how to measure the resistivity readings, how often the resistivity readings are checked, and how to accept or reject the resistivity readings. For instance, Batch# M0072809-3, dated July 28, 2009, was regenerated to fill (b)(4) resin tanks, and its (b)(4) resistivity readings were recorded at (b)(4) Mega ohms. One of the resin tanks (Tank Serial# (b)(4)) was later installed at a hospital for use in dialysis on August 11, 2009. Your firm verbally stated to the investigator that your firm used (b)(4) Mega ohms as the final test specification but did not document this verbal specification.
b. Your firm verbally stated that if the water rinse quality of a resin tank was less than (b)(4) Mega ohms of resistivity, your firm would rinse the tank longer, that if a tank failed to meet the (b)(4) Mega ohm resistivity, your firm would divert it for non-dialysis use, and that your firm performed pressure testing of each returned resin tank to detect leaks. These verbal requirements were not documented.
c. Your firm did not document if the carbon tanks and D1 resin tanks were re-rinsed and any testing performed prior to their delivery.
3. Failure to establish and maintain procedures to control labeling activities, as required by 21 C.F.R. § 820.120. FDA 483 Item 3. Specifically:
Your firm has not established written procedures for identifying labeling information, printing and applying labels on the carbon and D1 resin tanks, inspecting the labeling for accuracy, and documenting the labeling inspection results in the device history record. For instance, your firm applies a gray-color label on the mixed-bed resin tanks to prevent mixups with the other resin tanks intended for industrial applications, and a (b)(4) day installation sticker to control bacterial growth in the resin tanks. Your firm has not documented these requirements, and labeling inspections in the batch records (regeneration logs and exchange orders). Another instance, the installation date on the two resin tanks (Tank S/N (b)(4) and (b)(4)) at a hospital occurred a day before the tanks were actually filled at your firm as documented in their batch record.
4. Failure to establish and maintain data that clearly describes or references the specified requirements, including quality requirements, for purchased or otherwise received product and services, as required by 21 C.F.R. § 820.50(b). FDA 483 Item 4. Specifically:
a. Your firm has not requested from the foreign supplier certificates of analysis (COA) of the (b)(4) anion resin in order to verify that the received resin material conforms to the resin specifications or recognized AAMI standards for dialysis use. Your firm verbally stated that your supplier's sales representative kept the COA for you.
b. Your firm has not documented, approved, and maintained written specifications for the replacement carbon that was used to re-bed the carbon tanks, and the (b)(4) anion resin for the mixed-bed D1 tanks. Further, your firm verbally stated that you had changed the supplier of the carbon material in the last (2) years and had not documented a description of the change and approved the change.
5. Failure to validate and document with a high degree of assurance the results of a process that cannot be fully verified by subsequent inspection and test, and failure to have established procedures for such activities, as required by 21 C.F.R. § 820.75(a). FDA 483 Item 8. Specifically:
Your firm has not validated the resin regeneration process and documented the validation results for the type I mixed-bed D1 resin intended for dialysis use. Your firm verbally stated that it needed to get the exchange tanks out to the dialysis customers within (b)(4) days of the regeneration date but did not document the testing results of bacterial growth and water resistivity in the resin tanks in order to validate the (b)(4) day installation date (install by date). Further, you firm did not have schematics of your regeneration plant.
6. Failure to establish and maintain adequate procedures for quality audits and conduct such audits to assure that the quality system is in compliance with established quality system requirements and to determine the effectiveness of the quality system, as required by 21 C.F.R. § 820.22. FDA 483 Item 5. Specifically:
Your firm has not established written procedures for planning and conducting internal quality audits, and documenting the audit results and has not conducted quality audits.
Responding to This Warning letter
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 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 (21 C.F.R. Part 820) 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. Please 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.
Your response should be sent to Thao Ta, Compliance Officer, Dallas District Office, Food and Drug Administration, HFR-SW140, 4040 N. Central Expressway, Suite 300, Dallas, Texas 75204. If you have any questions about the content of this letter, please contact Mr. Ta at 214-253-5217.
Finally, you should know that 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 and to bring your products into compliance.
Sincerely,
/s/
Reynaldo R. Rodriguez
Dallas District Director
RRR:txt
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