FDA WARNING_LETTER - ARKRAY, Inc. - October 10, 2014

On April 10, 2015, the FDA issued a Warning Letter to Arkray, Inc. following an inspection from October 9-10, 2014, in Kyoto, Japan. The inspection revealed that Arkray's Hemoglobin A1c (HbA1c) HA-8180 and HA-8180V Analyzers are adulterated, as their manufacturing processes do not conform to the Quality System (QS) regulation (21 CFR Part 820).

The letter details six violations: 1. **Failure to establish and maintain design review procedures (21 CFR 820.30(e))**: Design review procedures for the HbA1c HA-8180V analyzer lacked requirements for appropriate stages of review and attendance by representatives from all functions and an independent individual. Arkray's proposed corrective actions were deemed inadequate as they did not confirm revision of the original procedure or include a systemic retrospective review of all designs. 2. **Failure to establish and maintain design verification procedures (21 CFR 820.30(f))**: The design verification procedure for the HbA1c Analyzer Instrument lacked adequate documentation requirements for results, dates, and individuals performing verification. Deficiencies were noted in two design verification tests, including unapproved protocols and missing results. Arkray's response was inadequate due to an unvalidated retrospective review timeframe and insufficient