April 29, 2026 FDA Warning Letter: Mukesh B. Chandre, M.D., MBBS/Ashirwad Hospital & Research Centre Cited for In Vivo Bioavailability-Bioequivalence Studies – Clinical

FDA Warning Letter — Violations FDA cited at Mukesh B. Chandre, M.D., MBBS/Ashirwad Hospital & Research Centre

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’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 circumstances that provided the prospective subject or the representative sufficient opportunity or information to consider whether or not to participate and that minimized the possibility of undue influence. Specifically, Section 1 of the informed consent form (ICF) stated that all reference to the words “study drug” throughout the ICF can mean Doxorubicin-Test and Doxorubicin-Reference. Section 10 of the ICF stated, “There is evidence that this study drug is effective and indicated in your disease condition.” In addition, Section 4 stated that liposomal doxorubicin is already appro