Warning Letter Record: Sourav K. Mishra, M.D. / All India Institute of Medical Sciences (2026-04-29) — In Vivo Bioavailability-Bioequivalence Studies – Clinical
Letter issued · posted to fda.gov .
Subject as published: In Vivo Bioavailability-Bioequivalence Studies – Clinical
TL;DR
The short version: FDA issued a Warning Letter to Sourav K. Mishra, M.D. / All India Institute of Medical Sciences on 2026-04-29 citing: In Vivo Bioavailability-Bioequivalence Studies – Clinical. Full letter: https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/sourav-k-mishra-md-all-india-institute-medical-sciences-724881-04292026
Argus analysis
Sourav K. Mishra, M.D. / All India Institute of Medical Sciences (MARCS-CMS 724881) received an FDA Warning Letter dated April 29, 2026 from the Center for Drug Evaluation and Research (CDER). The letter cites: In Vivo Bioavailability-Bioequivalence Studies – Clinical. FDA posts Warning Letters to fda.gov after an internal review period; this one was made public on May 19, 2026.
Bioequivalence-study letters cite the same 21 CFR Part 312 / Good Clinical Practice framework FDA applies to clinical investigators, focused specifically on the integrity of pharmacokinetic data used to support ANDA bioequivalence claims. Findings here can affect whether FDA continues to rely on the study site's data across multiple sponsors' applications.
FDA Warning Letters typically specify a 15-working-day response window for the recipient to detail corrective actions. Compliance teams at peer companies in the same general compliance category commonly use a newly published letter as a prompt to re-check their own procedures against the same citation, and to watch fda.gov for a close-out letter confirming the cited firm's corrective action was accepted — or, absent one, for escalation to import alert, injunction, or product seizure.
Severity context
Medium severity. Typically labeling, misbranding, or promotional-claim matters — most peer companies will revise SKU-level copy within the response window.
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 Sourav K. Mishra, M.D. / All India Institute of Medical Sciences MARCS-CMS 724881 — April 29, 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-45-04-02 Product: Drugs Recipient: Recipient Name Sourav K. Mishra, M.D. Sourav K. Mishra, M.D. / All India Institute of Medical Sciences Sijua, Patrapada Bhubaneswar 751019 Odisha India Issuing Office: Center for Drug Evaluation and Research (CDER) United States WARNING LETTER FDA Ref. No.: 26-HFD-45-04-02 Dear Dr. Mishra: This Warning Letter informs you of objectionable conditions observed during the U.S. Food and Drug Administration (FDA) inspection conducted at All India Institute of Medical Sciences in Bhubaneswar, Odisha, India, between March 17 and March 20, 2025. The investigator representing FDA reviewed your conduct of a clinical in vivo bioequivalence study (Protocol 0270-22, “A Multicenter, Open Label, Balanced, Randomized, Two-Treatment, Two-Period, Two-Sequence, Single Dose, Crossover, Bioequivalence Study between two formulations of Doxorubicin Hydrochloride Liposome Injection 20 mg/10 mL (50 mg/m 2 dose) (Doxorubicin-Test compared with Doxorubicin-Reference) in Patients with Advanced Ovarian Cancer”) of the investigational product doxorubicin hydrochloride liposome injection 20 mg/10 mL, performed for Qilu Pharmaceutical (Hainan) Co., Ltd. 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. From our review of the FDA Establishment Inspection Report and the documents submitted with that report, 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: 1. You failed to ensure that the investigation was conducted according to the investigational plan [21 CFR 312.60]. As a clinical investigator, you are required to ensure that your clinical investigations are conducted in accordance with the investigational plan. The investigational plan for Protocol 0270-22 2 required you to prohibit the use of cytochrome P450 CYP3A4 and CYP2D6 inhibitors to subjects during the entire study duration, and before baseline for at least five half-lives of the given drug, if given prior to the first dose of the study intervention. You failed to adhere to this requirement. Specifically, all three enrolled subjects were orally administered Aprecap (aprepitant), a moderate inhibitor of CYP3A4, during the study. Examples of these failures include: a. Subject (b)(6) signed the informed con…
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
- What FDA violations was Sourav K. Mishra, M.D. / All India Institute of Medical Sciences cited for?
- The FDA Warning Letter to Sourav K. Mishra, M.D. / All India Institute of Medical Sciences (issuing office: Center for Drug Evaluation and Research (CDER)) cites: In Vivo Bioavailability-Bioequivalence Studies – Clinical. Classification: Warning Letter.
- When did FDA issue the warning letter to Sourav K. Mishra, M.D. / All India Institute of Medical Sciences?
- FDA issued the letter (MARCS-CMS 724881) on 2026-04-29 and posted it publicly on fda.gov on 2026-05-19.
- Is the FDA warning letter to Sourav K. Mishra, M.D. / All India Institute of Medical Sciences 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/sourav-k-mishra-md-all-india-institute-medical-sciences-724881-04292026.
- What does a "medium" severity rating mean for this letter?
- Medium severity. Typically labeling, misbranding, or promotional-claim matters — most peer companies will revise SKU-level copy within the response window.
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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). Warning Letter Record: Sourav K. Mishra, M.D. / All India Institute of Medical Sciences (2026-04-29) — In Vivo Bioavailability-Bioequivalence Studies – Clinical. Digital Empire LLC. Retrieved from https://argushq.ai/fda/warning-letter/fda-wl-sourav-k-mishra-m-d-all-india-institute-of-medical-sciences-2026-04-29-warning-l
"Warning Letter Record: Sourav K. Mishra, M.D. / All India Institute of Medical Sciences (2026-04-29) — In Vivo Bioavailability-Bioequivalence Studies – Clinical." Argus HQ Research, Digital Empire LLC, 2026, argushq.ai/fda/warning-letter/fda-wl-sourav-k-mishra-m-d-all-india-institute-of-medical-sciences-2026-04-29-warning-l.
Argus HQ Research. "Warning Letter Record: Sourav K. Mishra, M.D. / All India Institute of Medical Sciences (2026-04-29) — In Vivo Bioavailability-Bioequivalence Studies – Clinical." Digital Empire LLC. Accessed July 13, 2026. https://argushq.ai/fda/warning-letter/fda-wl-sourav-k-mishra-m-d-all-india-institute-of-medical-sciences-2026-04-29-warning-l.
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title = {Warning Letter Record: Sourav K. Mishra, M.D. / All India Institute of Medical Sciences (2026-04-29) — In Vivo Bioavailability-Bioequivalence Studies – Clinical},
author = {{Argus HQ Research}},
year = {2026},
publisher = {Digital Empire LLC},
url = {https://argushq.ai/fda/warning-letter/fda-wl-sourav-k-mishra-m-d-all-india-institute-of-medical-sciences-2026-04-29-warning-l},
note = {Accessed: July 13, 2026}
}