# FDA WARNING_LETTER - Dongguan Jianwei Electronics Products Co., Ltd. - June 06, 2014

Source: https://www.keypedia.com/records/warning_letter/dongguan-jianwei-electronics-products-co-ltd/fcc837fa-86a0-4d18-b57a-9b821c5497e7

> FDA WARNING_LETTER for Dongguan Jianwei Electronics Products Co., Ltd. on June 06, 2014. Product: Devices. Access full analysis and detailed observations.

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## Details

- Record Type: WARNING_LETTER
- Company Name: Dongguan Jianwei Electronics Products Co., Ltd.
- Inspection Date: 2014-06-06
- Product Type: Devices
- Office Name: Center for Devices and Radiological Health
- Summary: On October 16, 2014, the FDA issued a Warning Letter to Dongguan Jianwei Electronics Products Co., Ltd. following a June 3-6, 2014 inspection. The inspection revealed that the firm's Class II digital infrared (IR) ear thermometers and digital oral thermometers were adulterated under 21 U.S.C. § 351(h) due to non-conformity with Quality System (QS) regulation (21 CFR Part 820).

Key violations included:
1.  **Failure to establish and maintain CAPA procedures (21 CFR 820.100(a)):** Procedures lacked requirements for verifying/validating CAPAs, implementing/recording changes, and disseminating information. Specific complaint investigations lacked documented dates/results, and a corrective action was not implemented before closure. The firm's response was inadequate as it did not address reviewing previous CAPA records.
2.  **Failure to establish and maintain complaint handling procedures (21 CFR 820.198(a)):** Procedures did not ensure uniform/timely processing (lacking timeframes or complaint number recording) or MDR reportability evaluation. A specific complaint lacked documentation for the decision not to investigate. The firm's response was inadequate, failing to indicate a retrospective review of complaints.
3.  **Failure to establish and maintain rework procedures (21 CFR

## Related Documents

- [WARNING_LETTER - 2015-07-02](https://www.keypedia.com/records/warning_letter/dongguan-jianwei-electronics-products-co-ltd/c0b2ddf4-dae2-4718-a4e8-8d2ca63b0613)

## Related Officers

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

Company: https://www.keypedia.com/companies/dongguan-jianwei-electronics-products-co-ltd/f4ce5665-10a2-416e-825d-fba9a9e98981

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