- Sagami Rubber Industries Co., Ltd.
- Issuing Office:
- Center for Devices and Radiological Health
| || |
Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
10903 New Hampshire Avenue
White Oak Building 66
Silver Spring, MD 20993
NOV 24, 2015
VIA UNITED PARCEL SERVICE
Sagami Rubber Industries Co., Ltd.
Dear Mr. Oato:
During an inspection of your firm located in Atsugi, Japanon July 21, 2015, through July 24, 2015, an investigator from the United States Food and Drug Administration (FDA) determined that your firm manufactures natural rubber latex 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 to affect the structure or function of the body.
Our inspection revealed that the condomsare 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 regarding the devices that is required by or under Section 519 of the Act, 21 U.S.C. § 360i, and 21 CFR Part 803 - Medical Device Reporting.
We received a response from Shigeo Tadenuma, Director, Healthcare Products Division, dated August 7, 2015, 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 the noted violation. Your firm’s responses, dated October 9, 2015, November 2, 2015, and November 18, 2015, to the Form FDA 483 (FDA 483), were not reviewed because they were not received within fifteen business days of issuance of the FDA 483. These responses will be evaluated along with any other written material provided in response to the violation cited in this Warning Letter. Significant deviations include, but are not limited to:
Failure to develop, maintain, and implement written MDR procedures, as required by 21 CFR 803.17. Specifically, your firm’s procedure, “Corrective and preventive action rule,” H-1 51, Ver 20, is not an MDR procedure. The scope of the document states, “(b)(4).” With the exception of a brief reference on page 19 to 30- and 5-day reports, the document does not contain information that would indicate that it was an MDR procedure created in accordance with the requirements in 21 CFR 803.17.
The adequacy of your firm’s response cannot be determined at this time. Your firm’s response states your firm is revising the procedure, “Corrective Action and Preventive Action Rule”, (H-1, 51/1721). However, your firm’s response did not include the revised procedure; without this documentation, FDA cannot make an assessment with respect to adequacy.
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.
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 violation, including an explanation of how your firm plans to prevent this violation, or similar violations, from occurring again. Include documentation of the corrections and/or corrective actions (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 Inspections Support Branch, White Oak Building 66, Rm 3523, 10903 New Hampshire Ave., Silver Spring, MD 20993.
Refer to CMS case #481765 when replying. If you have any questions about the contents of this letter, please contact LT David Dar, Acting Chief, Foreign Enforcement Branch, at firstname.lastname@example.org (email) or +1(240)402-4020 (telephone).
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 violation 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 violation, and take prompt actions to correct the violation and bring the products into compliance.
CAPT Sean M. Boyd, MPH, USPHS
Office of Compliance
Center for Devices and Radiological Health
David P. Mayer
1950 Addison Street, Suite 101
Berkeley, CA 94704
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