WARNING LETTER
Mukesh B. Chandre, M.D., MBBS/Ashirwad Hospital & Research Centre
MARCS-CMS 724911 —
April 29, 2026
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 approved by various regulatory authorities to treat the disease condition. Sections 4 and 10 also did not specify whether “liposomal doxorubicin” or “study drug”, and the statements concerning their approval or effectiveness, respectively, were applicable to the reference product or the test product. The lack of clarity may lead individuals to mistaken conclusions about the investigational product and whether it had already been demonstrated to be effective. Further, statements that overstate the possible benefit of the investigational product may unduly influence individuals to agree to participate when they might not otherwise do so.
In your May 28, 2025, written response to the Form FDA 483, you stated that the word “study drug” should have been described as “approved study drug”. You also stated that the Ethics Committee approved the ICF, you complied with all other requirements for the ICF, the ICF adequately described the risk of the test product in other sections, and you, as the clinical investigator, had consent discussions with trial participants that clarified the experimental nature, the associated risk, and that there is no guaranteed benefit of the test drug.
In addition, you stated that the CRO revised the global ICF template to improve the description of the study drugs and to improve the section describing the study drug benefits. You also stated that your site has taken the following corrective and preventive actions, including: (1) reviewed consent forms of ongoing studies; (2) notified the ethics committee of the inspectional observations; (3) revised the site’s SOP on the informed consent process to include a provision for the investigator or qualified staff to review the content of the informed consent document for compliance with regulatory requirements; and (4) trained site personnel on the revised SOP and regulatory guidance
While we acknowledge the corrective and preventive actions that your site has taken, your written response is inadequate because you did not provide sufficient details about how you, as the clinical investigator, will ensure adequate compliance with the informed consent regulations at 21 CFR part 50. Without this information, we are unable to determine whether your corrective actions appear adequate to prevent similar violations in future clinical investigations.
We emphasize that as the clinical investigator, you are ultimately responsible for compliance with all applicable FDA regulations governing the conduct of clinical investigations and the protection of human subjects, including obtaining legal effective informed consent from subjects before their enrollment. Your failure to obtain informed consent in accordance with 21 CFR part 50 before involving subjects in research jeopardizes the rights, safety, and welfare of subjects and raises concerns about whether subjects had an adequate opportunity to fully assess the risks and benefits of their participation in the clinical investigation.
This letter is not intended to be an all-inclusive list of deficiencies with your clinical study of an investigational product. It is your responsibility to ensure adherence to each requirement of the law and relevant FDA regulations. You should address any deficiencies and establish procedures to ensure that any ongoing or future studies comply with FDA regulations.
This letter notifies you of our findings and provides you with an opportunity to address the deficiencies noted above. Within 15 business days of your receipt of this letter, you should notify this office in writing of the actions you have taken to prevent similar violations in the future. Failure to address this matter adequately may lead to regulatory action without further notice to you. If you believe that you have complied with the FD&C Act and relevant regulations, please include your reasoning and any supporting information for our consideration.
Your written response, and any questions or concerns about this letter or the inspection, should be sent via email to the FDA at CDER-OSI-Communications@fda.hhs.gov.
Sincerely yours,
{See appended electronic signature page}
David C. Burrow, Pharm.D., J.D.
Director
Office of Scientific Investigations
Office of Compliance
Center for Drug Evaluation and Research
David Burrow Digitally signed by David Burrow
Date: 4/29/2026 12:30:34 PM EDT
______________________
1
In accordance with 21 CFR 320.31(c), the provisions of 21 CFR parts 312 and 50 are applicable to this bioequivalence study in humans because Protocol 0270-22 was conducted under an Investigational New Drug application (IND).
2
The exceptions provided in 21 CFR 50.22, 50.23, and 50.24 are not applicable here.
Content current as of:
05/12/2026
Regulated Product(s)
Drugs