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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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Fukuda Denshi Co, Ltd 2/21/12

  

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 

 

FEB 21 2012 
 
 
WARNING LETTER
 
 
 
VIA UNITED PARCEL SERVICE
 
Mr. Kotaro Fukuda
President and CEO
Fukuda Denshi Co, Ltd
39-4, Hongo-3-Chome, Bunkyo-Ku
Tokyo, 113-8483
Japan
 
Dear Mr. Fukuda:
 
During an inspection of your firm located in Tokyo, Japan,from October 31, 2011, through November 4, 2011, an investigator from the United States Food and Drug Administration (FDA) determined that your firm manufactures electrocardiogram monitoring equipment and software. 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 they are intended to affect the structure or function of the body.
 
Our inspection revealed that the devices are misbranded under section 502(t)(2) of the Act, 21 U.S.C. § 352(t)(2), in that your firm failed or refused to furnish material or information respecting the device that is required by or under section 519 of the Act, 21 U.S.C. § 360i, and 21 CFR Part 803 - Medical Device Reporting (MDR).  
 
We received a response from (b)(6) – Regulatory Affairs, dated November 23, 2011, concerning our investigator’s observations noted on the Form FDA 483 (FDA 483), List of Inspectional Observations, that 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 report to the FDA no later than 30 calendar days after the day that your firm received or otherwise became aware of information, from any source, that reasonably suggests that a device that it markets may have caused or contributed to a death or serious injury, as required by 21 CFR 803.50(a)(1).

For example, complaint 3000006537 describes an event where you firm’s device was a factor in the death of the patient as a result of user error.
 
We reviewed your firm’s response and conclude that it is not adequate. Your firm’srevised MDR Procedure entitled, (b)(4) draft version, is still inadequate in that it fails to address the deficiencies noted above. 
 
2. Failure to report to the FDA no later than 30 calendar days after the day that your firm received or otherwise became aware of information, from any source, that reasonably suggests that a device that it markets has malfunctioned and that this device or a similar device that your firm markets would be likely to cause or contribute to a death or serious injury if the malfunction were to recur, as required by 21 CFR 803.50(a)(2).

For example, complaint 3000007574 describes a malfunction of your firm’s device that resulted in the device burning. Your firm failed to conduct an investigation to confirm whether the device malfunctioned or whether the device’s components may have caused or contributed to the alleged incident. Without additional information from your firm indicating that the device did not malfunction, we can conclude that the information included for complaint 3000007574 reasonably suggests that the device marketed by your firm malfunctioned and that this device or a similar device would be likely to cause or contribute to a death or serious injury if the malfunction were to recur.

Please note that a malfunction that results in fire or burning of a medical device or its components, when that device or its components are used in an oxygen‑rich environment, should be reported at minimum as a malfunction because of the significant risk of permanent damage or harm to a patient.
 
We reviewed your firm’s response and conclude that it is not adequate. Your firm’srevised MDR Procedure entitled, (b)(4) draft version, is still inadequate in that it fails to address the deficiencies noted above. 
 
3. Failure to adequately develop, maintain and implement written MDR procedures, as required by 21 CFR 803.17.  For example, after reviewing your firm’s MDR procedure entitled,(b)(4) dated June 16, 2008, the following deficiencies were noted:

 
a. (b)(4) does not establish internal systems that provide for timely and effectively identification, communication, and evaluation of events that may be subject to MDR. For example:
 
i. (b)(4) combines language from requirements of other regulatory or competent authorities with those from Part 803. As written, the combination of this language with the MDR requirements will cause confusion leading to incomplete or inadequate reporting, or even non-reporting, of adverse events that meet the reportability requirements under Part 803.
 
ii. There are no instructions for conducting a complete investigation of each event and evaluating the cause of the event.

 
b. (b)(4) does not establish internal systems that provide for a standardized review procedure to determine when an event meets the criteria for MDR.  For example, (b)(4) does not include definitions of terms to identify events as reportable under MDR such as MDR reportable event, serious injury, malfunction, and caused or contributed.  Your firm must use these terms in its decision-making process to determine whether a complaint should be reported as an MDR, as required under 21 CFR 803.17(a)(2).

 
c. (b)(4) does not establish a process for documentation and record‑keeping requirements, including:,
 
i. Documentation of adverse event-related information maintained as MDR event files;
 
ii. Information that was evaluated to determine if an event was reportable; and
 
iii. Documentation of the deliberations and decision-making processes used to determine if a device-related death, serious injury, or malfunction was or was not reportable.
 
We reviewed your firm's response and conclude that it is not adequate. Your firm’srevised MDR Procedure, entitled (b)(4) draft version, is still inadequate in that it fails to address the deficiencies noted above. 
 
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 awarding of contracts.  
 
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, as well as 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 actions (including any systemic corrective actions) 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. Your firm’s response should be comprehensive and address all violations included in this Warning Letter.  Please provide a translation of documentation not in English to facilitate our review.
  
In addition, FDA has noted nonconformances regarding section 501(h) of the Act (21 U.S.C. § 351(h)), which are deficiencies pertaining to current good manufacturing practice requirements specified in the Quality System regulation found at 21 CFR Part 820. These nonconformities include, but are not limited to, the following:
 

1. Failure to promptly review, evaluate, and investigate complaints that represent an event which must be reported to FDA under Part 803, Medical Device Reporting, as required by 21 CFR 820.198(d). For example, 2 of the 11 total complaint records reviewed involving critical complaints, which were evaluated for MDR reportability and investigated, did not contain the dates and results of all of the investigations and also did not include documentation or references to all of the replies sent to the complainants. 

 
We reviewed your firm’s response and conclude that it is not adequate. Your firm provided a revised (b)(4), that included a reference to the (b)(4), which is filed with the complaint. However, your firm did not employ a systemic corrective action such as a retrospective review of past complaints to determine if any additional information was not properly documented.
 
2. Failure to document in the design history file (DHF) the results of the design validation, including identification of the design, methods, the date, and the individuals performing the validation, as required by 21 CFR 820.30(g). For example, the design validation testing conducted for the 7200 Design Project bedside monitor did not include the following in the DHF:
 
a. Documentation of the identification of the design configuration for the units used in the testing;
 
b. Documentation that acceptance criteria were documented or approved prior to starting the testing;
 
c. Documentation of the individuals performing the testing and the test dates; and
 
d. Explanations of the statistical methods used to analyze the data in the test plan or final report.

 
We reviewed your firm’s response and conclude that it is not adequate. Your firm stated that the market research report for DS-7200 would be revised to include the specific configurations, serial numbers, testing criteria/analysis, and other device details of the user and equipment used for market research. Your firm also stated that training would be provided to relevant personnel. However, no evidence was provided of implementation of this change and a retrospective review of other DHFs was not conducted to ensure that all the information contained within is adequate.
 
3. Failure to document in the DHF the results of the design verification, including identification of the design, methods, the date, and the individuals performing the verification, as required by 21 CFR 820.30(f). For example, the 7200 Design Project verification testing did not include documentation of the identification of the design for all the design verification testing conducted by your firm after the initial testing with prototypes failed. Your firm made corrections to the prototypes used in the testing after each failure of the verification testing. However, the dates of the corrections and the identification of the design after corrections were not documented in the DHF for the retests of the verification testing.
 
We are unable to determine the adequacy of your firm’s response at this time. Your firm’s response did not include evidence of the promised corrections and a retrospective review of other DHFs was not conducted to ensure all the information contained within is adequate.
 
Your firm’s response to this letter 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 2609, 10903 New Hampshire Ave., Silver Spring, MD 20993.  Refer to the Unique Identification Number (CMS Case #265276) when replying. If you have any questions about the contents of this letter, please contact: Joshua Simms, Cardiac Rhythm and Electrophysiology Devices Branch Chief at (301) 796-5599 or (301) 847-8128.
 
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,
/S/ 
Steven D. Silverman
Director
Office of Compliance
Center for Devices and Radiological Health