In Vivo Bioavailability-Bioequivalence Studies – Clinical: FDA Warning Letter to Pratik Doshi, M.D. / Alembic Pharmaceuticals Ltd., 2026-07-10
Letter issued · posted to fda.gov .
Subject as published: In Vivo Bioavailability-Bioequivalence Studies – Clinical
TL;DR
Here's the summary: The FDA's Center for Drug Evaluation and Research issued a warning letter (26-HFD-45-07-01) to Pratik Doshi, M.D. at Alembic Pharmaceuticals Ltd. on July 10, 2026, following an inspection of the Alembic Research Centre in Vadodara, India conducted March 3-7, 2025. The FDA found that the facility failed to obtain legally effective informed consent for a clinical in vivo bioequivalence study in violation of 21 CFR parts 50 and 312, specifically because the informed consent form stated "no part of it is of an experimental nature," which created inconsistencies and may have led subjects to mistaken conclusions about the study's experimental nature and unduly influenced their participation decisions. The facility responded by revising its informed consent procedures, updating templates to remove the problematic language, training personnel, and amending ongoing study ICFs with Ethics Committee approval.
Argus analysis
# FDA Warning Letter: Alembic Pharmaceuticals Ltd. — Informed Consent Violations
**Inspection Findings**
The FDA's Center for Drug Evaluation and Research (CDER) issued a Warning Letter on July 10, 2026, to Pratik Doshi, M.D., at Alembic Research Centre in Vadodara, India. Following a March 2025 inspection of the facility's bioequivalence study operations, investigators identified violations in the conduct of an in vivo bioequivalence clinical investigation. The FDA's Bioresearch Monitoring Program inspection examined whether the facility adequately protected human subject rights, safety, and welfare during the drug study.
**Regulatory Citations and Violations**
The primary violations cited 21 CFR Part 50 (Protection of Human Subjects) and 21 CFR Part 312 (Investigational New Drug Application). Specifically, the facility failed to obtain legally effective informed consent under 21 CFR 50.20. The informed consent form contained a problematic statement—"no part of it is of an experimental nature"—that contradicted the study's actual experimental classification. This language potentially misled subjects about the study's true nature and created confusion about whether procedures were experimental, information required under 21 CFR 50.25(a)(1). Such inconsistencies can unduly influence potential participants and prevent them from making fully informed decisions about enrollment.
**Response Timeline and Monitoring**
The facility had 15 business days from letter receipt to respond to the FDA. Dr. Doshi's March 26, 2025 response acknowledged the violations and described corrective actions, including revising standard operating procedures, updating consent form templates, and conducting personnel training. However, the FDA determined the response inadequate because it lacked sufficient documentation of revised informed consent forms with ethics committee approval and did not demonstrate the investigator's personal training on FDA regulations. Compliance officers should monitor for follow-up FDA correspondence, potential audit or enforcement actions, and whether the facility receives clearance to resume or initiate new clinical investigations.
Severity context
Low severity. Procedural or narrow scope; most peer companies resolve in the 15-business-day response window without structural change.
Regulatory background
FDA Warning Letters are administratively non-binding but signal that recurring non-compliance may escalate to injunction, seizure, import alert, or Application Integrity Policy invocation.
What peer compliance teams typically do next
Most compliance officers at peer companies use a Warning Letter against a named entity as a checklist for their own CAPA program. Common steps: pull the verbatim FDA letter; map each cited 21 CFR section against the team’s SOP library; confirm CAPA coverage; brief the QMR (Quality Management Review) on whether the cited subject matter is in scope for the next internal audit. The 15-business-day response window applies to the cited entity, not to peers — but a documented internal review against the cited subjects is what regulators expect to see if a peer is later inspected on the same topic.
Excerpt from the FDA Warning Letter (public domain, 17 USC §105)
WARNING LETTER Pratik Doshi, M.D. / Alembic Pharmaceuticals Ltd. MARCS-CMS 731020 — July 10, 2026 More Warning Letters Warning Letters About Warning and Close-Out Letters Delivery Method: VIA UNITED PARCEL SERVICE AND VIA E-MAIL Reference #: 26-HFD-45-07-01 Product: Drugs Recipient: Recipient Name Pratik Doshi, M.D. Pratik Doshi, M.D. / Alembic Pharmaceuticals Ltd. Alembic Research Centre Bioequivalence Facility, Alembic Road Next to Bhailal Amin General Hospital Gorwa Vadodara 390003 Gujarat India Issuing Office: Center for Drug Evaluation and Research (CDER) United States WARNING LETTER FDA Ref. No.: 26-HFD-45-07-01 Dear Dr. Doshi: This Warning Letter informs you of objectionable conditions observed during the U.S. Food and Drug Administration (FDA) inspection conducted at Alembic Research Centre in Vadodara, Gujarat, India, between March 3 and 7, 2025. The investigator representing FDA reviewed your conduct of a clinical in vivo bioequivalence study (Protocol (b)(4) , “ (b)(4) ”) of the investigational drug (b)(4) , performed for (b)(4) . This inspection was conducted as a part of FDA’s Bioresearch Monitoring Program, which includes inspections designed to evaluate the conduct of research and to help ensure that the rights, safety, and welfare of human subjects have been protected. At the conclusion of the inspection, the FDA investigator presented and discussed with you Form FDA 483, Inspectional Observations. We acknowledge receipt of your March 26, 2025, written response to the Form FDA 483. From our review of the FDA Establishment Inspection Report, the documents submitted with that report, and your written response dated March 26, 2025, it appears that you did not adhere to the applicable statutory requirements in the Federal Food, Drug, and Cosmetic Act (FD&C Act) and applicable regulations contained in Title 21 of the Code of Federal Regulations, parts 312 (21 CFR 312) and 50 (21 CFR 50) governing the conduct of clinical investigations and the protection of human subjects. 1 We wish to emphasize the following: You failed to obtain informed consent in accordance with the provisions of 21 CFR part 50 [21 CFR 312.60 and 21 CFR 50.20]. As a clinical investigator, you are required to obtain informed consent in accordance with 21 CFR part 50. FDA’s regulations at 21 CFR 50.20 state that, except as provided in 21 CFR 50.22, 50.23, and 50.24, 2 no investigator may involve a human being as a subject in research covered by the regulations unless the investigator has obtained the legally effective informed consent of the subject or the subject’s legally authorized representative. Under 21 CFR 50.20, “an investigator shall seek … [informed] consent only under circumstances that provide the prospective subject or the representative sufficient opportunity to consider whether or not to participate and that minimize the possibility of coercion or undue influence.” You failed to seek informed consent for the above-referenced clinical investigation under…
Excerpt only. The full verbatim Warning Letter is the source of truth — always read the original before regulatory decisions.
The verbatim FDA Warning Letter is the source of truth. Always read the original before acting on any analysis or summary on this page.
Read the full letter on fda.gov ↗Frequently asked questions
- When did FDA issue the warning letter to Pratik Doshi, M.D. / Alembic Pharmaceuticals Ltd.?
- FDA issued the letter (MARCS-CMS 731020) on 2026-07-10 and posted it publicly on fda.gov on 2026-07-21.
- Is the FDA warning letter to Pratik Doshi, M.D. / Alembic Pharmaceuticals Ltd. publicly available?
- Yes. The full verbatim letter is published at fda.gov. Argus HQ links directly to the source: https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/pratik-doshi-md-alembic-pharmaceuticals-ltd-731020-07102026.
- What does a "low" severity rating mean for this letter?
- Low severity. Procedural or narrow scope; most peer companies resolve in the 15-business-day response window without structural change.
- What is the regulatory background for a Warning Letter warning letter?
- FDA Warning Letters are administratively non-binding but signal that recurring non-compliance may escalate to injunction, seizure, import alert, or Application Integrity Policy invocation.
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methodology
The analysis above is produced by Anthropic Claude Haiku 4.5 against the verbatim FDA Warning Letter excerpt and is brand-voice lint-checked before publish. The TL;DR is the same summary that ships in the customer email digest. Severity is auto-classified by Argus from the subject string and letter body using rules documented in lib/ingestion/fda-warning-letters.ts.
Argus HQ is informational only. Summaries and analyses are AI-generated and may contain errors, misclassifications, or omissions. Verify against the FDA source URL above. Argus HQ is not a law firm, accounting firm, or regulatory agency, and provides no legal, accounting, financial, medical, or regulatory advice.
Compiled by Argus HQ Research from FDA primary sources · Reviewed by Andy Gaber, Founder
Cite this record
Reusing this data in reporting or research? Here’s a ready-made citation.
Argus HQ Research (2026). In Vivo Bioavailability-Bioequivalence Studies – Clinical: FDA Warning Letter to Pratik Doshi, M.D. / Alembic Pharmaceuticals Ltd., 2026-07-10. Digital Empire Holdings LLC. Retrieved from https://argushq.ai/fda/warning-letter/fda-wl-pratik-doshi-m-d-alembic-pharmaceuticals-ltd-2026-07-10-warning-letter
"In Vivo Bioavailability-Bioequivalence Studies – Clinical: FDA Warning Letter to Pratik Doshi, M.D. / Alembic Pharmaceuticals Ltd., 2026-07-10." Argus HQ Research, Digital Empire Holdings LLC, 2026, argushq.ai/fda/warning-letter/fda-wl-pratik-doshi-m-d-alembic-pharmaceuticals-ltd-2026-07-10-warning-letter.
Argus HQ Research. "In Vivo Bioavailability-Bioequivalence Studies – Clinical: FDA Warning Letter to Pratik Doshi, M.D. / Alembic Pharmaceuticals Ltd., 2026-07-10." Digital Empire Holdings LLC. Accessed July 23, 2026. https://argushq.ai/fda/warning-letter/fda-wl-pratik-doshi-m-d-alembic-pharmaceuticals-ltd-2026-07-10-warning-letter.
@misc{argushq_argushq_ai_fda_warning_letter_fda_wl_pratik_doshi_m_d_alembic_pharmaceuticals_ltd_2026_07_10_warning_letter_2026,
title = {In Vivo Bioavailability-Bioequivalence Studies – Clinical: FDA Warning Letter to Pratik Doshi, M.D. / Alembic Pharmaceuticals Ltd., 2026-07-10},
author = {{Argus HQ Research}},
year = {2026},
publisher = {Digital Empire Holdings LLC},
url = {https://argushq.ai/fda/warning-letter/fda-wl-pratik-doshi-m-d-alembic-pharmaceuticals-ltd-2026-07-10-warning-letter},
note = {Accessed: July 23, 2026}
}