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  5. SUZUKEN CO., LTD. OGUCHI CENTER - 06/11/2014
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United States

Issuing Office:
Center for Devices and Radiological Health

United States


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

Public Health Service
Food and Drug Administration
 10903 New Hampshire Avenue
Silver Spring, MD 20993 

JUN 11, 2014

Mr. Katsuya Iwasaki
General Manager
Kenz Product Department
Nagoya, Aichi 480-0125
Dear Mr. Iwasaki:
During an inspection of your firm located in Niwa-Gun, Nagoya, Aichi, Japan,on January 27, 2014, through January 30, 2014, an investigator from the United States Food and Drug Administration (FDA) determined that your firm manufactures Holter ECG monitoring medical devices and electrodes.  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 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.  We received a response from Mr. Masami Nakayashiki, Senior Manager, dated February 14, 2014, concerning our investigator’s observations noted on the Form FDA 483 (FDA 483), List of Inspectional Observations, which was issued to your firm. We address this response below, in relation to each of the noted violations. These violations include, but are not limited to, the following:
1.    Failure to establish and maintain procedures for implementing corrective and preventive action, as required by 21 CFR 820.100(a).
For example, your firm failed to establish procedures for assuring that problems that were identified as needing corrective actions were fully investigated; appropriate corrective actions were identified and implemented; and those corrective actions were verified. Seven CAPAs, opened between October 26, 2012, and October 21, 2013, did not include any actions to correct the identified issues.This is a repeat observation from the previous inspection.
The adequacy of the response cannot be determined at this time. Your firm indicated that it will review and complete all CAPAs as soon as reasonably possible and conduct training. However, no evidence was provided to determine if corrections have been completed.
2.    Failure to maintain complaint files and establish and maintain procedures for receiving, reviewing, and evaluating complaints by a formally designated unit, as required by 21 CFR 820.198(a).
For example, your firm’s complaint handling procedure, (b)(4), does not contain requirements to ensure that return material authorization (RMA) email requests are reviewed to determine if they should be documented under your firm’s complaint handling system. Your firm received emails alleging device failure for RMAs (b)(4) and either failed to document these as complaints or failed to document these in a uniform and timely manner. This is a repeat observation from the previous inspection.  
We reviewed your firm’s response and conclude that it is not adequate. Your firm indicated that it will include documentation of repair work to the customer complaint data and implement a controlled complaint database. However, your firm did not indicate that it will revise its procedures and retrospectively evaluate past return material authorization emails.
3.    Failure to review, evaluate, and investigate complaints involving the possible failure of a device, labeling, or packaging to meet any of its specifications unless such investigation has already been performed for a similar complaint and another investigation is not necessary, as required by 21 CFR 820.198(c).
For example, complaints (b)(4), and (b)(4) were not investigated because the devices were unavailable for evaluation due to being discarded after they were returned to your firm. This is a repeat observation from the previous inspection.
We reviewed your firm’s response and conclude that it is not adequate. Your firm’s response indicated that it will review and complete all complaints from 2013 and implement traceability every three months. However, your firm did not indicate whether it will revise its procedures and make other documented process changes to ensure that similar problems do not occur in the future.
4.    Failure to ensure that all inspection, measuring, and test equipment, including mechanical, automated, or electronic inspection and test equipment, is suitable for its intended purposes and is capable of producing valid results, as required by 21 CFR 820.72(a).
For example, your firm’s equipment purchasing procedure, (b)(4), does not ensure that equipment used to test finished devices is calibrated properly. The calibrated ranges of the DC Power Supply/Current Tester and the Current Leakage Tester do not encompass the levels used to test the SEER Light Holter Monitor.
We reviewed your firm’s response and conclude that it is not adequate. Your firm indicated that it will conduct training and revise the list of calibration specifications to match the standards of its equipment manufacturers who will conduct the calibration activities. However, your firm did not indicate that it will retrospectively evaluate past manufacturing records to determine if the use of improperly calibrated test equipment could have led to the release of nonconforming product.
U.S. 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 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 business days from the date you receive this letter of the specific steps your firm has taken to correct the noted violations, including 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 action (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.  Please provide a translation of documentation not in English to facilitate our review.
Your firm’s response should be sent to: Food and Drug Administration, Center for Devices and Radiological Health, Office of Compliance, Field Operations Branch, White Oak Building 66, Rm 2622, 10903 New Hampshire Ave., Silver Spring, MD 20993. Refer to CMS case 422711 when replying. If you have any questions about the contents of this letter, please contact: Daniel Walter, Chief, Foreign Enforcement Branch, at (301) 796-5587 (phone) or (301) 847-8139 (fax).
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. 
Sincerely yours,
Steven D. Silverman
Office of Compliance
Center for Devices and
    Radiological Health
US Agent
Tech-Med Services, Inc.
50 Route 111 Suite 300,
Smithtown, NY 11787 USA.

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