FDA WARNING_LETTER - Ross Healthcare Inc. - August 12, 2025

On February 12, 2026, the FDA issued a Warning Letter to AQ USA Inc., d.b.a Ross Healthcare Inc., following an inspection of their Lynden, WA drug manufacturing facility from July 30 to August 12, 2025. The agency found significant violations of Current Good Manufacturing Practice (CGMP) regulations for finished pharmaceuticals (21 CFR parts 210 and 211), rendering their drug products adulterated under the Federal Food, Drug, and Cosmetic Act.

Key issues identified included a failure to conduct appropriate laboratory testing for microbial contamination in finished drug products, inadequate microbial specifications, and insufficient testing of retain samples. The company also failed to establish and follow written procedures for components, using unapproved "filtered water" instead of USP purified water, and lacked proper supplier qualification for raw materials. Additionally, AQ USA Inc. failed to conduct identity testing for incoming components, relying on unverified supplier certificates of analysis. Significant deficiencies were also noted in the stability testing program, with no adequate data to support product shelf lives, and a general lack of effective oversight from the Quality Control Unit to ensure CGMP compliance.

The FDA requires the company to submit a detailed response within 15 working days, including action plans for comprehensive testing of distributed products, an independent assessment of laboratory and material systems, validation of component identity and supplier reliability, and a robust stability program. The agency also recommended engaging a qualified CGMP consultant to address systemic issues and ensure ongoing compliance.