FDA WARNING_LETTER - Omron (Dalian) Co., Ltd. Plant 1 - October 20, 2011

On February 14, 2012, the FDA issued a Warning Letter to Omron (Dalian) Co., Ltd. (Plant 1) following an inspection from October 17-20, 2011, which found their non-sterile blood pressure monitors to be adulterated. The firm's manufacturing, packing, storage, or installation methods did not conform to the Quality System regulation (21 CFR Part 820).

Key violations included: 1. Failure to establish and maintain adequate complaint handling procedures (21 CFR 820.198(a)), specifically lacking evaluation for Medical Device Reporting (MDR) requirements. The firm's response, citing a new corporate procedure, was deemed inadequate without submission of the procedure. 2. Failure to validate computer software used in production or the quality system (21 CFR 820.70(i)), with no documentation for the 6111 PCB check machine software. The firm's response lacked evidence of implementation. 3. Failure to ensure specified requirements for in-process product (21 CFR 820.80(c)), evidenced by operators retesting failed PCBs until they passed without documentation, and accepting PCB lots with incorrect sample sizes. The firm's response was inadequate, lacking evidence of re-sampling or a full evaluation of records. 4. Failure to establish and maintain Device