| Public Health Service Food and Drug Administration |
10903 New Hampshire Avenue |
Department of Health and Human ServicesDecember 15, 2010
WARNING LETTER
VIA United Parcel Service and Facsimile
Mr. Hiroshi Tanimitsu
President
JMS CO., Ltd.,
12-17, Kalo-Machi, Naka-Ku
Hiroshima, Japan 730-8652.
Dear Mr. Tanimitsu:
During an inspection of your firm located at 440 Ang Mio Kio, Industrial Park I, Singapore, on January 25-28, 2010, investigators from the United States Food and Drug Administration (FDA) determined that your firm manufactures Sterile A.V. Fistula Needles, Plasma Collection Set-LN620, I.V. Fluid Transfer Set-Scalp Vein and Blood Bags. 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.
This inspection revealed that your above-referenced 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 Title 21, Code of Federal Regulations (CFR), Part 803-Medical Device Reporting (MDR) regulation.
We received a response from your firm dated February 11, 2010, concerning our investigator’s observations noted on the FDA Form 483, List of Inspectional Observations that was issued to you. We address this response below, in relation to each of the noted violations. These violations include, but are not limited to, the following:
Failure to submit a report to the FDA, as soon as practicable but no later than 30 calendar days after becoming aware that one of your marketed devices may have caused or contributed to a death or serious injury, as required by 21 CFR 803.50(a)(1). For example:
Eleven (11) complaints received by your firm pertaining to the A.V. Fistula Needle products were reviewed during this inspection. Complaint number (b)(4), was received by the firm on October 27, 2009, regarding a needle stick injury. The facility reported that the employee was removing a needle from a patient and the employee was stuck by the needle. The patient involved was HIV positive and the user was treated with antiviral medications. According to the exhibit (# 22) submitted by your firm, the complaint report box checked under “Action” was: “Not Required.”
The complaint file was closed on November 9, 2009, and your firm determined that the complaint was not a reportable event. Complaint (b)(4) was not submitted as a MDR. However, the needle stick injury sustained by the employee did require medical intervention since the patient was HIV positive and the employee was given anti-viral treatment.
Your firm’s response dated February 11, 2010, is inadequate because the response did not address how your firm’s corrective action guideline will cover the MDR requirements in 21 CFR 803. Your firm’s response also stated that it is going to create a policy procedure which will include US requirements for MDR reportability. However, your firm did not specify and document how you will comply with this requirement. The response your firm submitted referenced compliance with 21 CFR 820 (complaint handling) but not 21 CFR 803 (medical device reporting).
Failure to include known or reasonably known information on the FDA Form 3500A report such as patient information: (1) Patient name or other identifier; (2) Patient age at the time of event, or date of birth;(3) Patient gender; and (4) Patient weight, as required by 21 CFR 820.52 (a)(1). For example:
The review of the eleven (11) MDRs showed that three (3) MDRs did not contain pertinent patient information on Block A of the MedWatch Form 3500A. This information was known because although the gender of the patient was not indicated on the form, the gender of the patient is reflected in the narrative text of the event.
Your firm’s response dated February 11, 2010, appears to be adequate because your Quality Management System was reviewed and it included a checkpoint in the current medical device reporting procedure ensuring that the needed information was accurately documented on the FDA Form 3500A. You stated that this checkpoint will be further documented in your Quality Procedure, QMS/RC-US/A- US Medical Device Reporting.
Please notify this office in writing within thirty (30) working days from the date you receive this letter of the specific steps you have taken to correct the noted violations, including an explanation of how you plan to prevent these violations, or similar violations, from occurring again. Include documentation of the corrective action you have taken. If your planned corrections will occur over time, please include a timetable for implementation of those corrections. If corrective action cannot be completed within 30 working days, state the reason for the delay and the time within which the corrections will be completed. Please provide a translation of any documents that is not written in English to facilitate our review.
Your response should be sent to Valerie A. Flournoy, Chief, General Hospital Devices Branch, Division of Enforcement-A, Office of Compliance, Food and Drug Administration at the address on this letterhead. If you have any questions concerning this matter, you may contact CAPT Balingit-Wines directly by telephone at 301-796-5497 or by email at ana.balingit-wines@fda.hhs.gov.
Finally, you should know that this letter is not intended to be an all-inclusive list of the violations at your facility. It is your 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 Form 483 (FDA 483), issued at the closeout of the inspection may be symptomatic of serious problems in your firm’s manufacturing and quality assurance systems.
You should investigate and determine the causes of the violations, and take prompt actions to correct the violations and to bring your products into compliance.
Sincerely yours,
/S/
Steven D. Silverman
Director
Office of Compliance
Center for Devices and
Radiological Health
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