FDA WARNING_LETTER - Sepal Reproductive Devices, Inc. - May 26, 2010

An FDA inspection of Sepal Reproductive Devices, Inc. in Boston, MA, from May 6-26, 2010, revealed that the firm's "Total Conception" devices are adulterated and misbranded. The devices are adulterated under section 501(h) of the Act because manufacturing methods, facilities, or controls do not conform to the Quality System (QS) regulation (21 CFR Part 820). Significant QS violations include the failure to establish and maintain procedures for corrective and preventive action (CAPA), purchasing controls, design changes, complaint handling, storage area controls, device master records (DMRs), device history records (DHRs), and quality audits. The firm lacked essential documentation and systems for these critical quality elements. Additionally, the devices are misbranded under section 502(t)(2) due to the firm's failure to develop and implement Medical Device Reporting (MDR) procedures (21 CFR 803.17). Further, the devices are adulterated under section 501(f)(1)(B) because there is no approved premarket approval (PMA) or investigational device exemption (IDE) in effect. They are also misbranded under section 502(o) for failing to submit a 510(k) premarket notification and under section 502(f)(1) because labeling lacks adequate directions for use (21 CFR 801.5, 801.109, 801.110). The FDA requires prompt corrective action within 15 working days, including a plan to prevent recurrence and supporting documentation. Failure to comply may result in regulatory actions such as seizure, injunction, civil penalties, and impact on federal contracts, PMA approvals, and Certificates to Foreign Governments.