Issued to Naveh Pharma LTD/Bigdam Inc.. Serious post-market compliance violation.
Issued
May 4, 2026Product
CGMP/Finished Pharmaceuticals/Adulterated/Unapproved New Drug
Company
Naveh Pharma LTD/Bigdam Inc.
Review center
CDERStage
Final Decision
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FDA issued a warning letter to Naveh Pharma LTD/Bigdam Inc. concerning CGMP/Finished Pharmaceuticals/Adulterated/Unapproved New Drug. Deterministic full-text screening identifies discussion of Labeling, claims, and misbranding, Manufacturing and CGMP controls, Quality systems and CAPA, Unapproved products and premarket authorization. Topic matches are navigation aids, not a legal conclusion; review the exact FDA web letter and any later response or closeout.
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Serious post-market compliance violation. Public notice requiring prompt remediation. FDA issued this letter on May 4, 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.