Issued to Pratik Doshi, M.D. / Alembic Pharmaceuticals Ltd.. Serious post-market compliance violation.
Issued
July 10, 2026Product
In Vivo Bioavailability-Bioequivalence Studies – Clinical
Company
Pratik Doshi, M.D. / Alembic Pharmaceuticals Ltd.
Review center
CDERStage
Final Decision
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FDA issued a warning letter to Pratik Doshi, M.D. / Alembic Pharmaceuticals Ltd. concerning In Vivo Bioavailability-Bioequivalence Studies – Clinical. Deterministic source-metadata screening identifies discussion of Clinical research and human-subject protections. 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 July 10, 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.