NINGBO HUAHUI MEDICAL INSTRUMENTS CO., LTD. – FDA Warning Letter, Apr 18, 2012

On July 16, 2012, the FDA issued a Warning Letter to Ningbo Huahui Medical Instruments Co., LTD, following an inspection from April 16-18, 2012. The inspection revealed that the firm's thermometers and blood pressure monitors, classified as devices, were adulterated under 21 U.S.C. § 351(h) due to non-conformity with the Quality System (QS) regulation (21 CFR Part 820). The firm's May 9, 2012, response to the FDA 483 was not reviewed as it was not received within 15 business days.

Violations included: 1. Failure to establish and maintain design control procedures (21 CFR 820.30(a)), with no documented evidence for design input, output, verification, validation, or review for the Digital Thermometer Model MT-518. 2. Failure to establish and maintain adequate complaint handling procedures (21 CFR 820.198(a)), specifically lacking evaluation for Medical Device Reporting (21 CFR 803) and failing to document customer communications. 3. Failure to adequately verify or validate corrective and preventive actions (CAPA) for effectiveness (21 CFR 820.100(a)(4)). 4. Failure to