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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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Okamoto Rubber Products Co., Ltd. 12/30/11


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 


DEC 30 2011 
Mr. Yoshiyuki Okamoto
Okamoto Industries Inc.
3-27-12, Hongo
Bunkyo-Ku, Tokyo, Japan
Dear Mr. Okamoto:
During an inspection of your firm located in Pathumthani, Thailand, on September 26 through September 29, 2011, an investigator from the United States Food and Drug Administration (FDA) determined that your firm manufactures Crown and CR Condoms.   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 function of the body.
Our inspection revealed that the Crown and CR Condoms 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 Title 21, Code of Federal Regulations (CFR), Part 803 - Medical Device Reporting.  These violations include, but are not limited to, the following:
Failure to adequately develop, maintain, and implement written MDR Procedures, as required by 21 CFR Part 803.17.  For example, the following failures were noted in your firm’s (b)(4), Rev. 6, effective date Dec. 20, 2010. Your firm’s procedure fails to establish a process that provides for:
(1) Timely and effective identification, communication, and evaluation of events that may be subject to MDR requirements. For example:
(a)   Your procedure, as written, combines language from requirements of other regulatory or competent authorities with those from 21 CFR Part 803.  This will result in incomplete, inadequate or even non-reporting of adverse events that meet the reportability requirements under 21 CFR Part 803.

(b)   There are no definitions of what your firm will consider to be a reportable event under 21 CFR Part 803.  To facilitate the correct interpretation of reportable events and to assure the quality of MDR submissions, the procedure should include definitions for become aware, caused or contributed, malfunction, MDR reportable event, and serious injury based on 21 CFR Part 803.3; reasonably known found in 21 CFR Part 803.50(b);and reasonably suggests found in 21 CFR Part 803.20(c)(1).

(c)   Your firm’s procedure states (b)(4).  Failure to consider events involving devices that are marketed outside of the U.S.A. may result in a failure to meet the reporting requirements in 21 CFR Part 803.50. Please refer to the definition of an MDR reportable event in 21 CFR Part 803.3.
(2) A standardized review process or procedure for determining when an event meets the criteria for reporting under 21 CFR Part 803. For example, there are no instructions for conducting a complete investigation of each event and evaluating the cause of the event.
(3)   Timely submission of complete medical device reports including:
(a)   Although your firm references the use of the FDA Form 3500A for submission of MDRs to the FDA, the procedure fails to include information about how to access the form and what types of information should be included on the FDA Form 3500A;
(b)   Circumstances under which an event must be submitted as a 30-day or 5-day report;
(c)   How your firm will submit all information reasonably known to it;
(d)   The circumstances under which your firm must submit a supplemental or follow-up report and the requirements for such reports;
(e)   How to submit reports for events that occur outside the U.S.A. As stated above, if an event involves a device that is the same or similar to a device with marketing approval in the U.S.A., then your firm must also evaluate these events for reportability and submit MDRs as required. 
(4)   Description for how your firm will address documentation and record-keeping requirements including:
(a)   Documentation of adverse event related information maintained as MDR event files;
(b)   Information that was evaluated to determine if an event was reportable;
(c)   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;
(d)   Systems that ensure access to information that facilitates timely follow-up and inspection by FDA.
In addition, your firm’s procedure includes references to baseline reports. Baseline reports are no longer required. We recommend that all references to a Baseline Report be removed from your firm’s MDR procedure (see: 73 Federal Register Notice 53686, dated September 17, 2008).
If your firm wishes to submit MDR reports via electronic submission it can follow the directions stated at the following URL:
If your firm wishes to discuss MDR reportability criteria, it may contact the MDR Policy Branch at 301-796-6670 or by email at MDRPolicy@fda.hhs.gov.
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 nonconformances include, but are not limited to, the following:
(1)  Failure to evaluate complaints to determine whether the complaint represents an event which is required to be reported to FDA under 21 CFR Part 803 of this chapter, Medical Device Reporting, as required by 21 CFR 820.198(a)(3). For example, a complaint was received by your firm on June 16, 2010, alleging condom failure which resulted in medical treatment. The complaint was not evaluated for reportability. The complaint investigation was limited to testing of retained samples. No investigation was made of the medical treatment or diagnosis to determine if a serious injury had occurred.
(2)  Failure to establish and maintain adequate schedules for the adjustment, cleaning, and other maintenance of equipment to ensure that manufacturing specifications are met, as required by 21 CFR 820.70(g)(1).  For example:
(a)  Maintenance activities for the (b)(4) machines have not been documented. The Yearly Maintenance Plan and Preventative Maintenance Plan for the (b)(4). No records exist to document the preventative maintenance (b)(4). No record exists to document the (b)(4).
(b)  In May 2011, no monthly check was documented for the visual inspection for (b)(4), as required by the Yearly Maintenance Plan and Preventative Maintenance Plan.
(3)  Failure to establish adequate procedures for identifying training needs and ensure that all personnel are trained to adequately perform their assigned responsibilities, as required by 21 CFR 820.25(b). For example, the production employee used the incorrect symbol in completing the Preventative Maintenance Check Sheet for the daily visual inspection of the lubricant sponges for June 2011 and August 2011.
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 CMS case #254174 when replying. If your firm has any questions about the contents of this letter, please contact: Paul F. Tilton, Chief, Ob/Gyn, Gastroenterology, and Urology Devices Branch, at 301-796-5770 or Fax 301-847-8137. 
Finally, your firm 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