Warning letterPosted July 21, 2026
FDA warning letter to Pratik Doshi, M.D. / Alembic Pharmaceuticals Ltd.
In Vivo Bioavailability-Bioequivalence Studies – Clinical
FDA posted a warning letter to Pratik Doshi, M.D. / Alembic Pharmaceuticals Ltd. on July 21, 2026; the letter is dated July 10, 2026. Subject: In Vivo Bioavailability-Bioequivalence Studies – Clinical. Issuing office: Center for Drug Evaluation and Research (CDER).
On the record
- Company
- Pratik Doshi, M.D. / Alembic Pharmaceuticals Ltd.
- Subject
- In Vivo Bioavailability-Bioequivalence Studies – Clinical
- Issuing office
- Center for Drug Evaluation and Research (CDER)
- Letter dated
- 2026-07-10
- Posted by FDA
- 2026-07-21
- Source
- FDA warning letters ↗
CFR cited
The record cites 7 sections of 21 CFR Parts 50, 312 and 320.
The full record
An account shows the violations FDA described and each CFR section it cited.
What a warning letter is
A warning letter is FDA's notice to a company that it found significant violations of federal requirements. FDA asks for a written response, normally within 15 working days. The letter is advisory: it states the agency's position and is not a final agency action.
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