# FDA WARNING_LETTER - Sagami Rubber Industries Co., Ltd. - July 24, 2015

Source: https://www.globalkeysolutions.net/records/warning_letter/sagami-rubber-industries-co-ltd/9d2cdbda-5720-4e5d-a106-9bcd8a8e198f

> FDA WARNING_LETTER for Sagami Rubber Industries Co., Ltd. on July 24, 2015. Product: Devices. Access full analysis and detailed observations.

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## Details

- Record Type: WARNING_LETTER
- Company Name: Sagami Rubber Industries Co., Ltd.
- Inspection Date: 2015-07-24
- Product Type: Devices
- Office Name: Center for Devices and Radiological Health
- Summary: On November 24, 2015, the FDA issued a Warning Letter to Sagami Rubber Industries Co., Ltd. following an inspection from July 21-24, 2015, at their Atsugi, Japan facility, which manufactures natural rubber latex condoms. The inspection revealed the condoms were misbranded under Section 502(t)(2) of the Act, 21 U.S.C. § 352(t)(2), due to the firm's failure to furnish required material or information under Section 519 of the Act, 21 U.S.C. § 360i, and 21 CFR Part 803 - Medical Device Reporting (MDR).

Specifically, the firm failed to develop, maintain, and implement written MDR procedures as required by 21 CFR 803.17. Their procedure, "Corrective and preventive action rule," H-1 51, Ver 20, was not an MDR procedure and lacked the necessary information, with only a brief reference to 30- and 5-day reports.

The firm's initial response dated August 7, 2015, was deemed inadequate as it stated a revision was underway but did not include the revised procedure. Subsequent responses from October and November 2015 were not reviewed due to late submission.

Sagami Rubber

## Related Officers

- [Office Director](https://www.globalkeysolutions.net/people/sean-m-boyd/e9ac4789-b489-402d-8fb7-e20eed2af01f)

Company: https://www.globalkeysolutions.net/companies/sagami-rubber-industries-co-ltd/f48669ab-9ca2-4d32-bcc1-861a0f4cecb3

Office: https://www.globalkeysolutions.net/offices/center-for-devices-and-radiological-health/9d89aff6-e435-4764-87be-f58c01aca7f7