FDA WARNING_LETTER - Jade & Pearl, Inc. - December 12, 2013

An FDA inspection of Jade & Pearl, Inc. from December 10-12, 2013, revealed significant violations concerning both medical devices and herbal tinctures. The firm manufactures Sea Pearls Sea Sponge Tampons, Premium Sea Pearls Sea Sponge Tampons, Sea Pearls for Pelvic Organ Prolapse, and reusable menstrual pads, which are deemed adulterated under 21 U.S.C. § 351(f)(1)(B) for lacking premarket approval (PMA) or investigational device exemption, and misbranded under 21 U.S.C. § 352(o) for failure to submit 510(k) notifications. Specific products like contraceptive sponges, tampons, and vaginal pessaries are classified as Class III or II devices requiring PMA or 510(k) clearance. The firm's medical devices are also misbranded under 21 U.S.C. § 352(t)(2) due to failure to develop and implement written Medical Device Reporting (MDR) procedures (21 CFR 803.17). Additionally, the firm failed to fulfill annual establishment registration and product listing requirements for fiscal year 2013, leading to further misbranding under 21 U.S.C. § 352(o). The firm's "Herbal Tincture" products are marketed as unapproved new drugs, violating 21 U.S.C. §§ 331 and 355, and are considered "new drugs" under 21 U.S.C. § 321(p) due to unproven claims. Several tinctures are also misbranded under 21 U.S.C. § 352(f)(1) for lacking adequate directions for use. Furthermore, the medical devices are adulterated under 21 U.S.C. § 351(h) due to non-conformity with Quality System (QS) regulations (21 CFR Part 820), including failures in complaint handling (820.198(a)), design controls (820.30(a)), nonconforming product control (820.90(a)), purchasing controls (820.50), acceptance activities (820.80(a)), corrective and preventive action (CAPA) procedures (820.100(a)), quality audits (820.22), and training procedures (820.25(b)). The firm's responses to these observations were deemed inadequate, often lacking timelines or documentation of corrective actions. The FDA requires prompt corrective action within fifteen business days, with potential regulatory actions including seizure, injunction, and civil money penalties for non-compliance.