Issued to Apollo Care, LLC. Serious post-market compliance violation.
Issued
February 2, 2026Product
Compounding Pharmacy/Adulterated Drug Products
Company
Apollo Care, LLC
Review center
CDERStage
Final Decision
Assyro regulatory brief
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FDA issued a warning letter to Apollo Care, LLC concerning Compounding Pharmacy/Adulterated Drug Products. Deterministic full-text screening identifies discussion of Manufacturing and CGMP controls, Labeling, claims, and misbranding, Quality systems and CAPA. 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 2, 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.