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

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