FDA WARNING_LETTER - Shanghai Ruike Sports Goods Co., LTD. - July 19, 2012

On November 23, 2012, the FDA issued a Warning Letter to Shanghai Ruike Sports Goods Co., LTD. following an inspection from July 16-19, 2012. The inspection revealed that the firm, which manufactures Class II motorized three-wheeled vehicles (devices), was not in conformity with the Quality System (QS) regulation (21 CFR Part 820), rendering their devices adulterated under section 501(h) of the Federal Food, Drug, and Cosmetic Act.

Key violations included: 1. Failure to establish and maintain complaint handling procedures (21 CFR 820.198(a)), specifically regarding evaluation for Medical Device Reporting (MDR) under 21 CFR 803. 2. Failure to ensure calibration standards for measuring equipment are traceable to national or international standards (21 CFR 820.72(b)(1)). 3. Failure to establish and maintain corrective and preventive action (CAPA) procedures, including documenting implementation of changes (21 CFR 820.100(a)(5)). Examples cited lack of documentation for enhanced incoming inspections and supplier notifications. 4. Failure to maintain complete Device Master Records (DMRs) (21 CFR 820.181), with the scooter model 3331 DMR lacking testing procedures. 5.