FDA WARNING_LETTER - AZ Instrument (Shen Zhen) Co., Ltd. - November 11, 2010

An FDA inspection of AZ Instrument (Shen Zhen) Co., Ltd. in Guangdong, China, from November 8-11, 2010, revealed that the firm's Glucose Test Strips, classified as medical devices, are adulterated. The manufacturing methods, facilities, and controls do not conform to the Current Good Manufacturing Practice (CGMP) requirements of the Quality System (QS) regulation (21 CFR Part 820). The firm's response to the FDA 483 was not reviewed due to late submission. Key violations include: 1) Failure to adequately validate processes where results cannot be fully verified by subsequent inspection and test, as required by 21 CFR 820.75. Specifically, the critical (b)(4) process for glucose test strips lacked full validation to establish capability and reproducibility. 2) Failure to establish and maintain adequate procedures to control nonconforming product, as required by 21 CFR 820.90(a). The firm's procedures did not detail how in-process nonconformities would be documented for trending or define thresholds for investigation. The FDA requires prompt corrective action. Failure to address these violations may lead to regulatory actions, including detention of devices entering the U.S., impact on federal contracts, and denial of premarket approvals for Class III devices and Certificates to Foreign Governments. The firm must notify the FDA within 15 working days with a detailed plan, including documentation and a timetable for corrections, and investigate the root causes of these systemic quality assurance issues.