FDA WARNING_LETTER - Okamoto Rubber Products Co., Ltd. - September 29, 2011

On September 26-29, 2011, an FDA inspection of Okamoto Industries Inc. in Pathumthani, Thailand, revealed that their Crown and CR Condoms, classified as medical devices, were misbranded. The misbranding stems from the firm's failure to furnish required material or information under section 519 of the Act and 21 CFR Part 803, specifically regarding Medical Device Reporting (MDR).

Key violations include: 1. **Inadequate MDR Procedures (21 CFR Part 803.17):** The firm's procedure (b)(4), Rev. 6, failed to establish processes for: * Timely identification, communication, and evaluation of reportable events, including combining FDA requirements with other authorities', lacking definitions for reportable events (e.g., "become aware," "serious injury"), and failing to consider events involving devices marketed outside the U.S. * A standardized review process for determining reportability, lacking instructions for complete event investigations. * Timely submission of complete MDRs, including how to access and complete FDA Form 3500A, circumstances for 30-day or 5-day reports, submission of all reasonably known information, requirements for supplemental reports, and submission of reports for events outside the U.S. * Documentation and record-keeping requirements, such as