Diamond Wipes International, Inc. – FDA 483, Oct 17, 2025

Diamond Wipes International, Inc., a drug manufacturer in Chino, CA, was subject to an FDA inspection from October 8 to October 17, 2025. The inspection identified several critical issues regarding the firm's compliance with Current Good Manufacturing Practices (cGMP), detailed in an FDA Form 483.

Key violations included a failure to thoroughly review out-of-specification (OOS) results. The water system, critical for drug manufacturing, showed Total Organic Carbon (TOC) levels exceeding limits, which the firm's quality unit failed to investigate in accordance with established procedures. This lapse raises concerns about potential drug product quality.

Significant data integrity deficiencies were also observed in the laboratory's computer systems. Analysts shared login credentials, allowing for untraceable actions, and possessed permissions to delete critical cGMP files, including raw test results. The absence of an effective audit trail system further compounded these issues, hindering the detection and investigation of missing records.

Additionally, the firm failed to adequately document established test procedures and laboratory control mechanisms at the time of performance. A notable instance involved missing water test results that were later discovered in biohazard waste, highlighting severe deficiencies in record-keeping and deviation handling.

Diamond Wipes International, Inc. must implement comprehensive corrective and preventive actions to address these observations and ensure full compliance with regulatory requirements for drug manufacturing.