FDA 483 - AQ USA, INC. - August 12, 2025

AQ USA, Inc., d.b.a Ross Healthcare Inc., a drug manufacturer in Lynden, WA, was inspected and cited for severe deficiencies across its quality system. The firm lacks an independent quality control unit, failed to establish adequate production and process controls, and demonstrated significant issues with laboratory records, stability testing, raw material control, and batch record completeness. These observations indicate a fundamental breakdown in ensuring drug product quality and compliance.