Warning Letter — Pratik Doshi, M.D. / Alembic Pharmaceuticals Ltd.
The FDA issued a Warning Letter to Pratik Doshi, M.D. and Alembic Pharmaceuticals Ltd. following an inspection by the Center for Drug Evaluation and Research (CDER).
Clinical investigators, pharmaceutical sponsors, and regulatory/compliance teams involved in drug development and clinical trial management.
This issuance indicates potential non-compliance with clinical trial regulations or Good Clinical Practice (GCP) standards. For regulatory professionals, it underscores the FDA's scrutiny of investigator conduct and sponsor oversight, which could lead to data integrity concerns or delays in drug approval processes if not addressed.
Ensure rigorous oversight of clinical investigators and study sites. Review clinical trial data for compliance with Good Clinical Practice (GCP) and ensure all investigator responsibilities are strictly documented and monitored.
FDA Warning Letter issued to: Pratik Doshi, M.D. / Alembic Pharmaceuticals Ltd.. 07/10/2026 — Center for Drug Evaluation and Research (CDER). Source: https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/pratik-doshi-md-alembic-pharmaceuticals-ltd-731020-07102026
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