FDA WARNING_LETTER - Richway NF - August 02, 2012

On January 9, 2013, the FDA issued a Warning Letter to Richway NF, a South Korean manufacturer of Biomat heating pad devices, following an inspection from July 30 to August 2, 2012. The inspection found the devices to be misbranded under section 502(t)(2) of the Act due to failure to comply with Medical Device Reporting (MDR) requirements (21 CFR Part 803).

Specifically, Richway NF failed to develop, maintain, and implement written MDR procedures (21 CFR 803.17). The firm's response, claiming Richway Inc. in Honolulu handles customer service and complaints, was deemed inadequate as it lacked evidence of implemented corrective actions and clarity on MDR reporting.

Additionally, the FDA identified quality system deficiencies under 21 CFR Part 820. These included: - Failure to establish and maintain complaint handling procedures (21 CFR 820.198(a)), with no complaint files maintained for the Biomat device. The firm's response was inadequate, lacking evidence of implemented procedures. - Failure to maintain complete Device History Records (DHRs) (21 CFR 820.184), specifically lacking evidence of final inspection, primary identification label location, and inclusion of all components for released devices. The firm's CAPA initiation and DHR checklist were noted, but