FDA WARNING_LETTER - Shantou Chaonan Liangying Hegao Plastic Toy Factory - July 17, 2014

On November 20, 2014, the FDA issued a Warning Letter to Elung Industrial Co., Ltd. following an inspection of their Shantou Chaonan Liangying Plastic Toy Factory from July 14-17, 2014. The inspection revealed that the firm's teething rings, classified as devices, were adulterated under 21 U.S.C. § 351(h) due to non-conformity with Quality System (QS) regulation (21 CFR Part 820) and misbranded under 21 U.S.C. § 352(t)(2) for failing to provide required information under 21 U.S.C. § 360i and 21 CFR Part 803 (Medical Device Reporting - MDR).

Key violations included: 1. **Failure to validate processes (21 CFR 820.75(a)):** The firm did not validate the (b)(4) process for sterile, fluid-filled teething rings. 2. **Failure to establish and maintain purchasing controls (21 CFR 820.50):** The firm did not ensure suppliers met criteria for the (b)(4) sterilization process. 3. **Failure to maintain complaint files and procedures (21 CFR 820.198):** The complaint handling procedure did