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

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