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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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Eiken Chemical Co., Ltd. 3/13/13


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

Public Health Service
Food and Drug Administration
 10903 New Hampshire Avenue
Document Control Room -WO66-G609
Silver Spring, MD 20993-0002 


March 13, 2013
Mr. Tetsuya Teramoto
President & CEO
Eiken Chemical Co.
143 Nogi
Nogi-Machi, Shimotsuga-Gun
Tochigi, 329-0114
Dear Mr. Teramoto:
During an inspection of your firm located in Tochigi, Japanon November 08 through November 09, 2012, an investigator from the United States Food and Drug Administration (FDA) determined that your firm manufactures fecal occult blood testing devices. 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.
Our inspection also revealed that the fecal occult blood testing devicesare adulterated under section 501(f)(1)(B) of the Act, 21 U.S.C. § 351(f)(1)(B), because your firm does not have an approved application for premarket approval (PMA) in effect pursuant to section 515(a) of the Act, 21 U.S.C. § 360e(a), or an approved application for an investigational device exemption under section 520(g) of the Act, 21 U.S.C. § 360j(g).  The device is also misbranded under section 502(o) the Act, 21 U.S.C. § 352(o), because your firm did not notify the agency of its intent to introduce the device into commercial distribution, as required by section 510(k) of the Act, 21 U.S.C. § 360(k).  For a device requiring premarket approval, the notification required by section 510(k) is deemed satisfied when a PMA is pending before the agency.  [21 CFR 807.81(b)]  The kind of information that your firm needs to submit in order to obtain approval or clearance for the device is described on the Internet at http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/HowtoMarketYourDevice/default.htm. The FDA will evaluate the information that your firm submits and decide whether the product may be legally marketed.
Also, 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 with regards to section 501(h) of the Act (21 U.S.C. § 351(h)), which are deficiencies within your firm’s quality system 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 adequately establish and maintain procedures for validating the device design as required by 21 CFR 820.30(g).
For example: Your firm failed to make a risk assessment after finding in October 2010 that samples are subject to significant hemoglobin deterioration when sample preparations are exposed to 37 degrees centigrade storage after approximately four days. The insert for the product that is distributed in the United States is included for the shipment by standard US mail. The insert states that the extracted feces may be stored at room temperature for up to 8 days. The test procedure section of the insert describes room temperature as 17 – 37 degrees centigrade.
The adequacy of the response dated 11/29/2012 cannot be determined at this time. Your firm’s response did not provide evidence of revision of “Rules for Design Control” and “Rules for Data Analysis.” Eiken Chemical stated that the QA division shall organize the quality system in order to implement the risk management activities effectively. All information from the US market and any new information found during the process of research and development will be used to perform effective risk assessment activities for the product marketed. Additionally, the Quality Assurance (QA) Division will revise the documented procedures “Rules for Design Control” and “Rules for Data Analysis.” Your firm stated this change would be complete March 2013.
2.    Failure to adequately review, evaluate, and investigate any complaint involving the possible failure of a device, labeling, or packaging to meet any of its specifications, as required by 21 CFR 820.198(c).
For example: Your firm’s complaint files are not complete. During the inspection of the Nasu facility it was found that there were (b)(4) complaints pertaining to OC products received between April 2012 and present. During the inspection of the Nogi facility it was found that the firm had received approximately (b)(4) service call complaints from the US distributor Polymedco between October 1 and 31, 2012. Service call complaints have not been investigated or treaded for potential corrective or preventive action. 
The adequacy of the response dated 11/29/2012 cannot be determined at this time. Your firm’s response did not provide evidence of revision of “Rules for Complaint Processing” and “Rules for Data Analysis.” The firm stated that the QA Department will analyze and assess the Technical Service Call History, analyze (b)(4) information from the US and input the analysis results into the management review. Your firm stated this change would be complete February 2013.
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 # 392732 when replying. If you have any questions about the contents of this letter, please contact: James Woods at (310) 796-6225.
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,
Alberto Gutierrez
Office of InVitro Diagnostics and Radiological Health
Center for Devices and Radiological Health