FDA WARNING_LETTER - Omron Healthcare, Inc. - February 16, 2007

The FDA issued a Warning Letter to Omron Healthcare, Inc. following an inspection from January 25 to February 16, 2007, identifying significant violations of medical device regulations. As an initial importer and distributor of foreign-manufactured diagnostic and therapeutic medical devices, Omron's products were deemed adulterated under 21 U.S.C. 351(h) due to non-conformity with Quality System (QS) regulation (21 CFR Part 820) and misbranded under 21 U.S.C. 352(t)(2) for failing to comply with Medical Device Reporting (MDR) requirements (21 CFR Part 803).

Key QS violations included failures in establishing and maintaining corrective and preventive action (CAPA) procedures, inadequate complaint handling (a repeat observation), insufficient computer software validation, lack of procedures for incoming product acceptance, absence of a designated quality system management representative, and deficiencies in document control and supplier quality requirements. MDR violations encompassed failures to submit timely and complete reports for deaths, serious injuries, and malfunctions to FDA and manufacturers, and incomplete written MDR procedures.

The FDA found several of Omron's responses inadequate, particularly regarding complaint records, software validation, and MDR procedures. The letter mandates prompt corrective action, requiring a written response within 15 working days detailing specific steps, preventive measures, and a timetable for completion. Failure to comply could result in regulatory actions such as seizure, injunction, civil money penalties, and impact federal contracts, premarket approvals, and Certificates to Foreign Governments. The letter also highlighted deficiencies in recall reporting under 21 CFR Part 806.