FDA Cites Mukesh B. Chandre, M.D., MBBS/Ashirwad Hospital & Research Centre in 2026-04-29 Warning Letter — In Vivo Bioavailability-Bioequivalence Studies – Clinical
Letter issued · posted to fda.gov .
Subject as published: In Vivo Bioavailability-Bioequivalence Studies – Clinical
TL;DR
Here's the summary: FDA issued a Warning Letter to Mukesh B. Chandre, M.D., MBBS/Ashirwad Hospital & Research Centre 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/mukesh-b-chandre-md-mbbsashirwad-hospital-research-centre-724911-04292026
Argus analysis
Mukesh B. Chandre, M.D., MBBS/Ashirwad Hospital & Research Centre (MARCS-CMS 724911) 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 12, 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
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 Mukesh B. Chandre, M.D., MBBS/Ashirwad Hospital & Research Centre MARCS-CMS 724911 — 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-45-04-01 Product: Drugs Recipient: Recipient Name Mukesh B. Chandre, M.D., MBBS Mukesh B. Chandre, M.D., MBBS/Ashirwad Hospital & Research Centre Maratha Section, Near Jijamata Udhyan Ulhasnagar 421004 Maharashtra India Issuing Office: Center for Drug Evaluation and Research (CDER) United States WARNING LETTER FDA Ref. No.: 26-HFD-45-04-01 Dear Dr. Chandre: This Warning Letter informs you of objectionable conditions observed during the U.S. Food and Drug Administration (FDA) inspection conducted at Ashirwad Hospital & Research Centre in Ulhasnagar, Maharashtra, India, between May 5 and May 9, 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. At the conclusion of the inspection, the FDA investigator presented and discussed with you the Form FDA 483, Inspectional Observations. We acknowledge receipt of your May 28, 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 May 28, 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’…
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 is the standard FDA response window for a warning letter?
- FDA warning letters typically require a written response within 15 working days of receipt, outlining the corrective and preventive actions the company will take.
- Has Mukesh B. Chandre, M.D., MBBS/Ashirwad Hospital & Research Centre had FDA enforcement actions before?
- This is the only FDA Warning Letter Argus HQ has on file for Mukesh B. Chandre, M.D., MBBS/Ashirwad Hospital & Research Centre as of 2026-05-12. Argus ingests new FDA enforcement records daily.
- What FDA violations was Mukesh B. Chandre, M.D., MBBS/Ashirwad Hospital & Research Centre cited for?
- The FDA Warning Letter to Mukesh B. Chandre, M.D., MBBS/Ashirwad Hospital & Research Centre (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 Mukesh B. Chandre, M.D., MBBS/Ashirwad Hospital & Research Centre?
- FDA issued the letter (MARCS-CMS 724911) on 2026-04-29 and posted it publicly on fda.gov on 2026-05-12.
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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). FDA Cites Mukesh B. Chandre, M.D., MBBS/Ashirwad Hospital & Research Centre in 2026-04-29 Warning Letter — In Vivo Bioavailability-Bioequivalence Studies – Clinical. Digital Empire LLC. Retrieved from https://argushq.ai/fda/warning-letter/fda-wl-mukesh-b-chandre-m-d-mbbs-ashirwad-hospital-and-research-centre-2026-04-29-warni
"FDA Cites Mukesh B. Chandre, M.D., MBBS/Ashirwad Hospital & Research Centre in 2026-04-29 Warning Letter — In Vivo Bioavailability-Bioequivalence Studies – Clinical." Argus HQ Research, Digital Empire LLC, 2026, argushq.ai/fda/warning-letter/fda-wl-mukesh-b-chandre-m-d-mbbs-ashirwad-hospital-and-research-centre-2026-04-29-warni.
Argus HQ Research. "FDA Cites Mukesh B. Chandre, M.D., MBBS/Ashirwad Hospital & Research Centre in 2026-04-29 Warning Letter — In Vivo Bioavailability-Bioequivalence Studies – Clinical." Digital Empire LLC. Accessed July 13, 2026. https://argushq.ai/fda/warning-letter/fda-wl-mukesh-b-chandre-m-d-mbbs-ashirwad-hospital-and-research-centre-2026-04-29-warni.
@misc{argushq_argushq_ai_fda_warning_letter_fda_wl_mukesh_b_chandre_m_d_mbbs_ashirwad_hospital_and_research_centre_2026_04_29_warni_2026,
title = {FDA Cites Mukesh B. Chandre, M.D., MBBS/Ashirwad Hospital & Research Centre in 2026-04-29 Warning Letter — 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-mukesh-b-chandre-m-d-mbbs-ashirwad-hospital-and-research-centre-2026-04-29-warni},
note = {Accessed: July 13, 2026}
}