WARNING LETTER
Vedic Lifesciences Pvt. Ltd.
MARCS-CMS 722446 —
March 09, 2026
Delivery Method:
VIA UNITED PARCEL SERVICE AND VIA E-MAIL
Reference #:
26-HFD-45-03-02
Product:
Drugs
Recipient:
Recipient Name
Jayesh Chaudhary
Recipient Title
CEO
Vedic Lifesciences Pvt. Ltd.
203, Morya Landmark 1, Off New Link Road
Andheri West
Mumbai
400053
Maharashtra
India
Issuing Office:
Center for Drug Evaluation and Research (CDER)
United States
WARNING LETTER
FDA Ref. No.: 26-HFD-45-03-02
Dear Mr. Chaudhary:
This Warning Letter informs you of objectionable conditions observed during the U.S. Food and Drug Administration (FDA) inspection conducted between January 13 and 15, 2025. The investigators representing FDA reviewed the role of Vedic Lifesciences Pvt. Ltd. (Vedic) as the testing facility of the following nonclinical laboratory studies of the investigational drug
(b)(4)
, performed for
(b)(4)
.:
• Study No.
(b)(4)
: “
(b)(4)
”
• Study No.
(b)(4)
: “
(b)(4)
”
• Study No.
(b)(4)
: “
(b)(4)
”
This inspection was conducted as part of FDA’s Bioresearch Monitoring Program, which includes inspections designed to evaluate the conduct of research and to help ensure the quality and integrity of study data, in accordance with Title 21 of the Code of Federal Regulations, part 58 (21 CFR 58), Good Laboratory Practice for Nonclinical Laboratory Studies.
At the conclusion of the inspection, the FDA investigators presented and discussed with you the Form FDA 483, Inspectional Observations. We acknowledge receipt of your February 3, 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 February 3, 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 21 CFR 58 governing the conduct of nonclinical laboratory studies. We wish to emphasize the following:
You failed to prepare a final report for each nonclinical laboratory study that includes, but is not limited to, the following: (1) name and address of the testing facility; (2) name of the study director and other scientists or professionals involved in the study; (3) locations where all specimens, raw data, and final reports are to be stored; and (4) study director’s signature and date [21 CFR 58.185(a)(1), 58.185(a)(10), 58.185(a)(13), and 58.185(b)].
A final report must be prepared for each nonclinical laboratory study and must contain certain information, including but not limited to: (1) the name and address of the testing facility performing the study; (2) the names of the study director and other scientists or professionals involved in the study; and (3) the location where all specimens, raw data, and the final report are stored. The final report must also be signed and dated by the study director.
You failed to adhere to these requirements. Specifically, the final reports for studies
(b)(4)
that Vedic submitted to the sponsor did not contain complete and accurate information for the above-described items that were required to be included in the final report. Examples include but are not limited to the following:
1. The final reports for studies
(b)(4)
did not accurately identify the testing facility that performed the studies. Specifically, the testing facility that performed studies
(b)(4)
was
(b)(4)
(
(b)(4)
), and the testing facility that performed Study
(b)(4)
was
(b)(4)
(
(b)(4)
). However, before submitting the final reports to the sponsor, Vedic changed the final reports to falsely include the name and address of Vedic as the testing facility that performed the study.
2. The final reports for studies
(b)(4)
did not include the correct names of the study director and other scientists or professionals involved in the study, such as the quality assurance unit (QAU) personnel. Specifically, before submitting the final reports to the sponsor, Vedic changed the final reports provided by the testing facilities that performed the study to falsely include the names of Vedic personnel as the study director or QAU personnel.
3. The final reports for studies
(b)(4)
did not accurately identify the storage location for all specimens, raw data, and final reports. Specifically, before submitting the final reports to the sponsor, Vedic changed the final reports to falsely identify Vedic as the storage location; however, all specimens, raw data, and final reports were stored at
(b)(4)
for studies
(b)(4)
, and at
(b)(4)
for Study
(b)(4)
, the testing facilities that actually performed these studies.
4. The study directors for studies
(b)(4)
and
(b)(4)
did not sign the final reports for these studies. In accordance with 21 CFR 58.33, the study director is the individual responsible for the overall conduct of the study. For these three studies, Vedic personnel signed the final reports. However, the Vedic personnel who signed the final reports were not involved in the conduct of these studies because the studies were performed at other testing facilities. Therefore, the Vedic personnel who signed the final reports were not the individuals responsible for the overall conduct of the studies. As a result, the final reports for studies
(b)(4)
, and
(b)(4)
did not include accurate study director signatures.
We acknowledge that some of these findings were not included on the Form FDA 483 you received, and therefore your written response does not directly address all the violations discussed in this letter.
However, during the inspection, the Manager of Quality Assurance stated that Vedic personnel do not serve as study directors, Vedic does not maintain study archives, Vedic has never had an animal facility, and Vedic is not a testing facility where the toxicology studies are conducted. Additionally, in your February 3, 2025, written response to the Form FDA 483, you acknowledged that Vedic outsourced Studies
(b)(4)
to
(b)(4)
, and Study
(b)(4)
to
(b)(4)
. You stated that Vedic is not a toxicology testing facility and instead operates as a liaison to prospective clients who are looking to conduct toxicology studies. You stated that it was your earlier practice to withhold from sponsors the names and contact information of partner testing facilities, study directors, QAU personnel, and archive locations to “prevent circumvention by the testing facility.” You further stated that in accordance with Vedic’s standard operating procedure (SOP), the Vedic study monitor was the single point of study control and therefore was captured as the single point of study control in the reports.
In your written response, you stated that as part of your corrective and preventive actions, since 2022, you have stopped mentioning Vedic as a testing facility, and the details of the testing facility are now shared with the study sponsors. You also stated that you realized that your practice of listing the Vedic study monitor as the single point of study control in reports is not correct, and that the actual study director is now mentioned in final reports. You also stated that you amended the final report for Study
(b)(4)
to add the name of the correct testing facility and study director. However, since the
(b)(4)
testing facility has closed its operations, you were unable to retrieve and amend the study reports for Studies
(b)(4)
. Additionally, you stated that you revised your SOP for Toxicological Operations to implement the following practices: (1) The name and address of the study director will be included in the final report; (2) Vedic will be identified as the sponsor representative in the study plan and report; (3) the Vedic study monitor will sign the study plan and report; and (4) testing facility management of the GLP facility will ensure that the study director approves the study plan and report.
While we acknowledge the actions that your site has taken and plans to take, your written response is inadequate because you did not provide sufficient details about your corrective action plan. Specifically, you did not provide sufficient details about the procedures and practices for preparing final reports that have been or will be implemented at your site to prevent similar violations in the future. For example, you did not provide details regarding any training for Vedic personnel on your updated procedures and practices. Also, the SOP that you provided does not include all the practices identified in your written response, such as including the name and address of the study director in the final report. Without this information, we cannot undertake an informed evaluation of your written response, and it is not clear whether your corrective and preventive actions will adequately ensure that ongoing and future studies will be conducted in compliance with applicable FDA regulations, including the requirements for preparing final reports.
Failure to include accurate and complete information in the final study report raises significant concerns about the quality and integrity of the study records and data from Studies
(b)(4)
. The final study report of an investigation is crucial to the reconstruction of the events that led to the collection and reporting of the data, and it must contain accurate and complete information regarding the conduct of the study. The information in these essential documents forms the basis for establishing scientific interpretations and conclusions and must therefore reflect all circumstances affecting the quality and integrity of the data.
We further emphasize that nonclinical laboratory studies submitted to FDA must be accurately and completely reported in accordance with FDA regulations, to ensure the quality and integrity of study data. Your failure to provide final reports for all three studies, containing accurate and complete information that is required to be submitted to support FDA’s review of a nonclinical laboratory study, raises significant concerns about the validity and integrity of the data that were collected and submitted for these nonclinical laboratory studies.
This letter is not intended to be an all-inclusive list of deficiencies with the nonclinical laboratory studies of investigational drugs for which Vedic was the testing facility, as represented in final reports submitted to FDA. 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.
Should you have any questions or concerns about this letter or the inspection, please email FDA at CDER-OSI-Communications@fda.hhs.gov.
Your written response and any pertinent documentation should be addressed to:
Brittany L. Garr, MPH
Branch Chief
Compliance Enforcement Branch
Division of Enforcement and Postmarketing Safety
Office of Scientific Investigations
Office of Compliance
Center for Drug Evaluation and Research
U.S. Food and Drug Administration
Building 51, Room 5352
10903 New Hampshire Avenue
Silver Spring, MD 20993
Sincerely,
{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
U.S. Food and Drug Administration
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This is a representation of an electronic record that was signed electronically. Following this are manifestations of any and all electronic signatures for this electronic record.
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/s/
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DAVID C BURROW
03/09/2026 10:48:01 AM
Content current as of:
03/17/2026
Regulated Product(s)
Drugs