Issued to AQ USA Inc., d.b.a Ross Healthcare Inc.. Serious post-market compliance violation.
Issued
February 12, 2026Product
CGMP/Finished Pharmaceuticals/Adulterated
Company
AQ USA Inc., d.b.a Ross Healthcare Inc.
Review center
CDERStage
Final Decision
Assyro regulatory brief
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FDA issued a warning letter to AQ USA Inc., d.b.a Ross Healthcare Inc. concerning CGMP/Finished Pharmaceuticals/Adulterated. Deterministic source-metadata screening identifies discussion of Manufacturing and CGMP controls. Topic matches are navigation aids, not a legal conclusion; review the exact FDA web letter and any later response or closeout.
Review the exact FDA warning letter, cited violations, requested corrections, and any later response or closeout before assessing current status.
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Serious post-market compliance violation. Public notice requiring prompt remediation. FDA issued this letter on February 12, 2026.
The firm is expected to respond in writing, normally within 15 working days, describing corrective actions and timelines. FDA verifies remediation — often through reinspection — and issues a closeout letter when violations are corrected. Unresolved warning letters can escalate to import alerts, seizure, or injunction.