FDA Warning Letter Highlights Quality Failures at Washington Drug Facility

The U.S. Food and Drug Administration (FDA) issued a warning letter dated 12 February 2026 following an inspection conducted in August 2025 at a pharmaceutical manufacturing facility, AQ USA Inc., d.b.a. Ross Healthcare Inc. in Lynden, Washington. The inspection revealed significant quality control deficiencies that raised concerns about product safety and regulatory compliance.

One of the primary findings involved inadequate microbiological testing of finished drug products. Inspectors reported that the company failed to establish appropriate specifications for objectionable microorganisms and did not ensure that every batch was tested before release, leaving no documented evidence that products met microbiological quality standards.

The FDA also identified weaknesses in material handling procedures and supplier oversight. The firm relied on supplier certificates of analysis without verifying their reliability and released products using insufficiently tested components.

Additional concerns included the absence of a comprehensive stability testing program and insufficient oversight by the facility’s Quality Unit, which failed to ensure proper laboratory control and data integrity.

The FDA has requested a detailed remediation plan, including an independent laboratory assessment, retrospective batch evaluation, validated analytical methods, and a scientifically robust stability program.

09-03-2026