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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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Minntech Corporation 25-Apr-06

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

Public Health Service
Food and Drug Administration


Minneapolis District office
Central Region
212 Third Avenue South
Minneapolis, MN 55401
Telephone: (612)785-7133
FAX: (612) 334-4142

April 25, 2006



Roy K. Malkin
President and Chief Executive Officer
Minntech Corporation
14605, 28th Avenue North
Plymouth, Minnesota 55447-4822

Dear Mr. Malkin:

During an inspection of your establishment located in Plymouth, Minnesota, on November 30, 2005 - January 11, 2006, our investigators determined that your firm manufactures dialysis products, chemical sterilants, and fiber filters. These products are devices as defined by Section 201(h) of the Federal Food, Drug, and Cosmetic Act (the Act).

The above-stated inspection revealed that these devices are adulterated under 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 conformance with the Current Good Manufacturing Practice {CGMP) requirements for medical devices which are set forth in the Quality System regulation, as specified in Title 21, Code of Federal Regulations (CFR), Part 820. Significant deviations include, but are not limited to, the following :

1. Failure to adequately ensure that when the results of a process cannot be fully verified by subsequent inspection and test, the process shall be validated with a high degree of assurance and approved according to established procedure, as required by 21 CFR 820.75(a). Specifically:

a. A top level validation of the entire water system has not been performed. The [redacted] gallon water system loop on the RO water system has not been validated.

b. The [redacted] step that is performed on [redacted] filters has not been validated.

2. Failure to fully investigate a complaint involving the possible failure of a device to meet its specifications, which is required by 21 CFR 820.198(c). Specifically, a complaint reported that [redacted] cartridge had been found to be contaminated with [redacted] bacteria. Investigation of this complaint included testing of the RO water system, but when microbial growth was found, the growth was not always identified and speciated.

3. Failure to document corrective and preventive action activities, including investigations of causes of nonconformities, as required by 21 CFR 820 .100(b). Specifically, CAR 3746 did not document that, [redacted] disinfectant recommended by [redacted] to sanitize units in the field caused [redacted] in the cartridges.

4. Failure to establish procedures to prevent contamination of equipment or product by substances that could reasonably be expected to have an adverse effect on product quality, which is a requirement of 21 CFR 820.70(e). Seriocomically, a cleaning process was not established for the equipment used in the [redacted] process.

5. Failure to define and implement process control procedures that are necessary to ensure conformance to specifications as required by 21 CFR 820.70(a). Specifically:

a. Document 20100-048, Quantitative Microbe Analysis of Water Samples, Revision B, section IV. 9., page 3, required that microbial growth be further isolated and tested to identify specific organisms present. This was not being done.

b. Document 20102-016, Sanitation of [redacted] Gal. RO System, Revision G, section IX., lists the RO Drop Locations that are to be checked during and after the sanitation process. The RO-3 (molding) did not have an opening, and thus it was impossible to check that location as required by the procedure.

6. Failure to implement document control procedures, which are required by 21 CFR 820.40. Specifically, documents are not properly reviewed prior to issuance of a new revision. Procedure 20002-089, Sampling and Release Criteria for RO/DI Water, Revision H, section III. E. 3., page 4, referenced an obsolete procedure (20100-032).

This letter is not intended to be an all-inclusive list of deficiencies at your facility. It is your ~responsibility to ensure adherence to each requirement of the Act and regulations. The specific violations noted in this letter and in the Form FDA-483 issued at the close of the inspection may be symptomatic of serious underlying problems in your firm's manufacturing and quality assurance systems. You are responsible for investigating and determining the causes of the violations identified by the FDA. You also must promptly initiate permanent corrective and preventive action on your quality system.

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, no premarket approval applications for Class III devices to which the Quality System regulation deficiencies are reasonably related will be approved until the violations have been corrected. Also, no requests for Certificates to Foreign Governments will be granted until the violations related to the subject devices have been corrected.

You should take prompt action to correct these deviations. Failure to promptly correct these deviations may result in regulatory action being initiated by the Food and Drug Administration without further notice. These actions include, but are not limited to, seizure, injunction, and/or civil money penalties.

We have received and reviewed the January 17, March 1, and March 30, 2006, letters from Craig Smith, Vice President Regulatory Affairs and Quality Assurance, which describe corrective actions taken by your firm to address the FDA-483 Inspectional Observations. Your firm's actions appear to be appropriate except as noted below.

Regarding FDA-483 observation #4, we do not agree with your decision not to speciate the organisms found during your testing of the RO water system. First, you stated that your procedures do not require that organisms be speciated. However, as noted in FDA-483 observation #7, Document 20100-048, Quantitative Microbe Analysis of Water Samples, Revision B, section IV. 9., page 3, required that microbial growth be further isolated and tested to identify specific organisms present. Secondly, you stated that there was no need to know what the organism was because you were preparing to sanitize the entire system and knowledge of what organism was present would not have affected that sanitization. Even if that information would not have affected the sanitization, a determination of the organism(s) present in your water system would have resulted in a more complete follow-up of the complaint involving possible [redacted] contamination.

Regarding FDA-483 observations #7 and 8, your actions appear to be limited to correction of the specific deviations that were cited in the FDA-483. Please explain what you have done to determine whether or not these observations are indicators of more widespread problems with these areas of your quality system.

In order to fully assess the adequacy of your corrective actions, the Minneapolis District Office will conduct a follow-up inspection in the near future.

Please notify this office in writing within 15 working days of receipt of this letter to provide an update on the status of your corrective actions and to address the issues noted above. Your response should be sent to Timothy G. Philips, Compliance Officer, at the address on this letterhead.

H. Tom War wick for W. Charles Be coat
Minneapolis District