FDA WARNING_LETTER - Dongguan Yongrong Plastic Products Co., Ltd. - March 23, 2012

The FDA inspected Dongguan Yongrong Plastic Products Co., Ltd. in China from March 19-23, 2012, and determined that their fluid-filled teething rings, classified as devices, are adulterated under section 501(h) of the Federal Food, Drug, and Cosmetic Act. This adulteration stems from non-conformity with the current good manufacturing practice requirements of the Quality System regulation (21 CFR Part 820). Key violations included the failure to establish and maintain adequate procedures for monitoring and controlling process parameters for validated processes (21 CFR 820.75(b)), inadequate process control procedures (21 CFR 820.70(a)), sampling plans not based on a valid statistical rationale (21 CFR 820.250(b)), and insufficient procedures for acceptance of incoming product (21 CFR 820.80(b)). The firm's April 3, 2012, response to the FDA 483 observations was deemed inadequate, lacking comprehensive corrective and preventive action plans. As a result, the firm's products are subject to refusal of admission into the U.S. under section 801(a) of the Act. The FDA requires a written response within fifteen business days detailing specific, systemic corrective actions, prevention plans, and a timetable for completion, with supporting documentation. Non-compliance may also impact federal contracts, Class III device approvals, and Certificates to Foreign Governments.