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

Source: https://www.keypedia.com/records/warning_letter/shantou-chaonan-liangying-hegao-plastic-toy-factory/2bef0651-2b9b-47b6-920d-3579ee687557

> FDA WARNING_LETTER for Shantou Chaonan Liangying Hegao Plastic Toy Factory on July 17, 2014. Product: Devices. Access full analysis and detailed observations.

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## Details

- Record Type: WARNING_LETTER
- Company Name: Shantou Chaonan Liangying Hegao Plastic Toy Factory
- Inspection Date: 2014-07-17
- Product Type: Devices
- Office Name: Center for Devices and Radiological Health
- Summary: 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

## Related Officers

- [President](https://www.keypedia.com/people/steven-d-silverman/06ce6082-cb19-469c-bcba-c368d335b0df)

Company: https://www.keypedia.com/companies/shantou-chaonan-liangying-hegao-plastic-toy-factory/689e9e13-8484-4136-8d8d-05506359d231

Office: https://www.keypedia.com/offices/center-for-devices-and-radiological-health/9d89aff6-e435-4764-87be-f58c01aca7f7