FDA WARNING_LETTER - Reka Health Pte Ltd - August 21, 2014

On August 18-21, 2014, an FDA inspection of Reka Health Pte Ltd. in Singapore found their Reka E100 cardiac rhythm monitor to be misbranded and adulterated. The device was misbranded under section 502(t)(2) of the Act for failing to furnish required information under section 519 and 21 CFR Part 803 (Medical Device Reporting). Specifically, the firm failed to develop, maintain, and implement written MDR procedures as required by 21 CFR 803.17, including requirements for event identification, review, timely transmission, and record-keeping. The firm's response did not address this violation.

The device was also adulterated under section 501(h) of the Act, as manufacturing methods, facilities, or controls did not conform to the Quality System regulation (21 CFR Part 820). Significant violations included: 1. Failure to establish and maintain corrective and preventive action (CAPA) procedures (21 CFR 820.100(a)). The firm's CAPA procedure lacked requirements for analyzing quality data, using statistical methodology, and verifying/validating CAPA effectiveness. The firm's response was inadequate, as deficiencies in examined CAPAs were not corrected, closed CAPAs did not comply with updated procedures, and personnel were not trained. 2. Failure to establish