WARNING LETTER
Dabur India Limited
MARCS-CMS 728828 —
July 24, 2026
Delivery Method:
Via Electronic Mail - Return Receipt Requested
Reference #:
320-26-105
Product:
Drugs
Over-the-Counter Drugs
Recipient:
Recipient Name
Mr. Mohit Malhotra
Recipient Title
Chief Executive Officer
Dabur India Limited
Dabur Corporate Office, Kaushambi
Sahibabad
Ghaziabad
201010
India
Issuing Office:
Center for Drug Evaluation and Research (CDER)
United States
Warning Letter
320-26-105
July 24, 2026
Dear Mr. Malhotra:
The United States Food and Drug Administration (FDA) inspected your drug manufacturing facility, Dabur India Limited, FEI 3001413302, at Survey No. 225/4/1, Village: Saily, Silvassa, Dadra and Nagar Haveli and Daman and Diu, from January 12 to 16, 2026.
This warning letter summarizes significant violations of Current Good Manufacturing Practice (CGMP) regulations for finished pharmaceuticals. See Title 21 Code of Federal Regulations (CFR), parts 210 and 211 (21 CFR parts 210 and 211).
Because your methods, facilities, or controls for manufacturing, processing, packing, or holding do not conform to CGMP, your drug products are adulterated within the meaning of section 501(a)(2)(B) of the Federal Food, Drug, and Cosmetic Act (FD&C Act), 21 U.S.C. 351(a)(2)(B).
We reviewed your February 4, 2026 response to our Form FDA 483 in detail.
During our inspection, our investigator observed specific violations including, but not limited to, the following.
1. Your firm failed to establish an adequate quality control unit with the responsibility and authority to approve or reject all components, drug product containers, closures, in-process materials, packaging materials, labeling, and drug products and the authority to review production records to assure that no errors have occurred or, if errors have occurred, that they have been fully investigated (21 CFR 211.22(a)).
Your firm manufactures over-the-counter drug products including
(b)(4)
and
(b)(4)
. Your quality unit (QU) failed to exercise its authority and responsibilities over your drug manufacturing operations, including ensuring the integrity of your production records.
During the inspection, our investigator requested the equipment usage logbook for Unit
(b)(4)
, Line
(b)(4)
, which your management stated was dedicated exclusively to
(b)(4)
manufacturing. Your firm delayed providing this record for several days. When your firm finally produced the logbook, it appeared to have been newly created. Subsequently, our investigator discovered the original logbook in the document room. A comparison of the two logbooks revealed that the version provided to our investigator was falsified. The fraudulent logbook listed entries only for
(b)(4)
. It deliberately omitted multiple U.S. marketed OTC drug products that were documented in the original logbook, including
(b)(4)
.
Furthermore, our investigator identified multiple discrepancies between the source data in your analytical data books and the final values reported in your batch manufacturing records or certificates of analysis. For multiple batches of
(b)(4)
and
(b)(4)
, the reported values for quality attributes such as residue on ignition, melting range, pH, and viscosity did not match the original data. While these inaccuracies did not involve out-of-specification results, your QU signed off on these records without ensuring the consistency and accuracy of the data.
In your response, you acknowledge these deficiencies, attributing the falsified logbook to “inadequate documentation controls, insufficient oversight, and lack of robust governance.” You attributed other data inaccuracies to your transcription practices and inadequate resources within your QU for proper review. You state that you trained personnel on data integrity and committed to revising procedures and reviewing only the
(b)(4)
of data for similar transcription errors. You also commit to sending “
(b)(4)
samples of impacted drug product including
(b)(4)
” to a contract testing laboratory.
Your response is inadequate because it fails to address the severity of the observed data integrity failures. Your proposed corrective actions address the data integrity breaches as isolated procedural gaps rather than as evidence of a systemic breakdown in QU oversight and a deficient quality culture. Your response does not address the fundamental failure of your QU to ensure the integrity and completeness of all data related to your drug manufacturing operations, nor does it include an adequate assessment of the potential impact on the quality of drug products already distributed to the U.S. market. Furthermore, your response lacks a sufficient comprehensive evaluation of your QU’s capabilities to fulfill all required quality-related functions.
Your firm’s quality systems are inadequate. See FDA’s guidance document
Quality Systems Approach to Pharmaceutical CGMP Regulations
for help implementing quality systems and risk management approaches to meet the requirements of CGMP regulations 21 CFR, parts 210 and 211 at https://www.fda.gov/media/71023/download.
In response to this letter, provide:
A comprehensive assessment of documentation systems used throughout your manufacturing and laboratory operations to determine where documentation practices are insufficient. Include a detailed corrective action and preventive action (CAPA) plan that comprehensively remediates your firm’s documentation practices to ensure you retain attributable, legible, complete, original, accurate, contemporaneous records throughout your operation.
A comprehensive assessment and remediation plan to ensure your QU is given the authority and resources to effectively function. The assessment should also include, but not be limited to:
o A determination of whether procedures used by your firm are robust and appropriate
o Provisions for QU oversight throughout your operations to evaluate adherence to appropriate practices
o A complete and final review of each batch and its related information before the QU disposition decision
o Oversight and approval of investigations and discharging of all other QU duties to ensure identity, strength, quality, and purity of all products.
2. Your firm failed to ensure that laboratory records included complete data derived from all tests necessary to ensure compliance with established specifications and standards (21 CFR 211.194(a)).
Your laboratory records did not include complete data to support the analyses performed. For example, your analytical notebooks documented approximately
(b)(4)
microbiology plates for finished drug products and approximately
(b)(4)
media plates for testing
(b)(4)
samples as incubated, but the plates were physically absent from incubators with no documented explanation about their whereabouts or disposal. In addition, during the inspection you could not produce the test procedures, analytical workbooks, or test data sheets to support the reported certificate of analysis results for approximately
(b)(4)
batches of U.S. marketed drug products. You also failed to make the required entries in your equipment logbooks to reflect the use of multiple instruments for the specific batch release tests performed.
In your response, you indicate that a microbiologist inadvertently discarded the missing microbiological plates due to lack of training. You state that you retrained the microbiologist, re-analyzed the missing finished drug product plates, and introduced a new controlled logbook to improve sample traceability.
Regarding the batches released without supporting analytical records, you commit to sending samples for several of the batches to a contract laboratory for retrospective testing and to implementing formal test data sheets for future data recording. Further, you state that you have retrained the personnel responsible for failing to document instrument usage and that you will discontinue the use of separate equipment usage logbooks once the new data sheets are implemented.
Your response is inadequate because it does not adequately address major deficiencies in your laboratory system. Your response does not address your oversight of data integrity including, but not limited to, improving your quality assurance function. Your response does not provide a comprehensive retrospective risk assessment or complete testing of all potentially impacted drug products within expiry and fails to adequately assess and mitigate the risk to consumers.
Reliability of data is fundamentally compromised when there is a failure to record data or to maintain complete and accurate records of test results. Furthermore, the lack of reliable data compromises the ability of your QU to exercise its function of ensuring compliance to applicable standards.
Your quality system does not adequately ensure the accuracy and integrity of data to support the safety, effectiveness, and quality of the drugs you manufacture. See FDA’s guidance document
Data Integrity and Compliance With Drug CGMP: Questions and
Answers
for guidance on establishing and following CGMP compliant data integrity practices at https://www.fda.gov/media/119267/download.
We strongly recommend that you retain an independent third-party qualified consultant to assist in your remediation. In response to this letter, provide:
A comprehensive investigation into the extent of the inaccuracies in data records and reporting. Your investigation should include:
o A detailed investigation protocol and methodology; a summary of all laboratories, manufacturing operations, and systems to be covered by the assessment; and a justification for any part of your operation that you propose to exclude.
o Interviews of current and former employees to identify the nature, scope, and root cause of data inaccuracies. We recommend that these interviews be conducted by a qualified third party.
o An assessment of the extent of data integrity deficiencies at your facility. Identify omissions, alterations, deletions, record destruction, non-contemporaneous record completion, and other deficiencies. Describe all parts of your facility’s operations in which you discovered data integrity lapses.
o A comprehensive retrospective evaluation of the nature of all data integrity deficiencies. We recommend that a qualified third party with specific expertise in the area where potential breaches were identified should evaluate all data integrity lapses.
A current risk assessment of the potential effects of the observed failures on the quality of your drugs. Your assessment should include analyses of the risks to patients caused by the release of drugs affected by a lapse of data integrity and analyses of the risks posed by ongoing operations.
A management strategy for your firm that includes the details of your global corrective action and preventive action plan. Your strategy should include:
o A detailed corrective action plan that describes how you intend to ensure the reliability and completeness of all the data you generate including analytical data, manufacturing records, and all data submitted to FDA.
o A comprehensive description of the root causes of your data integrity lapses including evidence that the scope and depth of the current action plan is commensurate with the findings of the investigation and risk assessment. Indicate whether individuals responsible for data integrity lapses remain able to influence CGMP-related or drug application data at your firm.
o Interim measures describing the actions you have taken or will take to protect patients and to ensure the quality of your drugs, such as notifying your customers, recalling product, conducting additional testing, adding lots to your stability programs to assure stability, drug application actions, and enhanced complaint monitoring.
o Long-term measures describing any remediation efforts and enhancements to procedures, processes, methods, controls, systems, management oversight, and human resources (e.g., training, staffing improvements) designed to ensure the integrity of your company’s data.
o A commitment to have a qualified consultant conduct extensive annual audits, for at least two years, to assist in evaluating CAPA effectiveness after you have executed your data integrity remediation protocol.
o Inform FDA if you will be hiring a Chief Integrity Officer who is fully empowered to receive anonymous complaints from employees reporting data integrity concerns and with the authority to ensure any potential breach is promptly investigated (by independent quality assurance function, along with expertise from outside entities whenever needed).
o A status report for any of the above activities already underway or completed.
3. Your firm failed to establish and follow adequate written procedures for cleaning and maintenance of equipment (21 CFR 211.67(b)).
You failed to demonstrate that your cleaning practices are adequate to remove potential contaminants and to prevent drug product carry over in shared equipment used to manufacture your OTC drug products.
For example, your cleaning validation program for the non-dedicated Unit
(b)(4)
Line
(b)(4)
relied exclusively on the visual inspection of
(b)(4)
to determine adequate cleaning. Your cleaning validation program lacked scientifically determined maximum allowable carryover limits, quantitative residue testing, or direct surface sampling of difficult-to-clean areas. In addition, you did not perform any cleaning validation for Unit
(b)(4)
Line
(b)(4)
despite using it to manufacture at least
(b)(4)
different OTC drug products.
In your response, you acknowledge the deficiencies in your cleaning validation program. You commit to enhancing your cleaning validation program by developing validated analytical methods, establishing carryover limits, implementing direct surface swab sampling, and revalidating the cleaning process. You stated that Line
(b)(4)
is now dedicated to a
(b)(4)
drug product, and you are conducting a limited retrospective quality review by testing only
(b)(4)
samples for potential cross-contamination.
Your response is inadequate because it does not address the interim controls you will implement to mitigate the risk of cross-contamination during your remediation period. Additionally, testing only
(b)(4)
samples from the
(b)(4)
batches manufactured on Line
(b)(4)
is statistically insufficient to assess the potential for cross-contamination. Further, your response also does not include a retrospective review of all drug products released to the U.S. market and within expiry for potential cross-contamination resulting from the use of a non-validated cleaning process on non-dedicated equipment.
Inadequate removal of active ingredients and drug product residues from surfaces of non-dedicated manufacturing equipment can lead to contamination of drug products subsequently manufactured on that equipment.
In response to this letter, provide:
Your CAPA plan to implement routine, vigilant operations management oversight of facilities and equipment. This plan should incorporate oversight from a qualified independent consultant and ensure, among other things, prompt detection of equipment/facilities performance issues, effective execution of repairs, adherence to appropriate preventive maintenance schedules, timely technological upgrades to the equipment/facility infrastructure, and improved systems for ongoing management review. Your plan should also ensure that appropriate actions are taken throughout the company network.
A comprehensive, independent retrospective assessment of your cleaning effectiveness to evaluate the scope of cross-contamination hazards. Include the identity of residues, other manufacturing equipment that may have been improperly cleaned, and an assessment whether cross-contaminated drug products may have been released for distribution. The assessment should identify any inadequacies of cleaning procedures and practices, and encompass each piece of manufacturing equipment used to manufacture more than one drug product.
Appropriate improvements to your cleaning validation program, with special emphasis on incorporating conditions identified as worst case in your drug manufacturing operation. This should include but not be limited to identification and evaluation of all worst-case:
o drugs with higher toxicities
o drugs with higher drug potencies
o drugs of lower solubility in their cleaning solvents
o drugs with characteristics that make them difficult to clean
o swabbing locations for areas that are most difficult to clean
o maximum hold times before cleaning
In addition, describe the steps that must be taken in your change management system before introduction of new manufacturing equipment or a new drug product.
A summary of updated SOPs that ensure an appropriate program is in place for verification and validation of cleaning procedures for drug products, processes, and equipment.
4. Your firm failed to establish adequate written procedures for production and process control designed to assure that the drug products you manufacture have the identity, strength, quality, and purity they purport or are represented to possess, and your firm’s quality control unit did not review and approve those procedures, including any changes (21 CFR 211.100(a)).
You failed to validate your manufacturing process for your OTC drug products. During the inspection, you stated that you had not performed process validation for
(b)(4)
of the
(b)(4)
drug products you manufacture on Unit
(b)(4)
lines. You also stated you had not performed process validation for
(b)(4)
of the
(b)(4)
drug products you manufacture on Unit
(b)(4)
lines.
In your response, you acknowledge the lack of process validation for most of your drug products and commit to preparing process validation plans and protocols using a campaign-based approach.
Your response is inadequate because it does not provide a schedule or timeframes for completing process validation activities for each of your drug products. Furthermore, your response lacks an interim plan, such as enhanced finished drug product testing, for any drugs manufactured and distributed before these validation activities are completed to ensure you produce drug products of acceptable quality. You also did not provide drug product impact assessments for U.S. distributed drug products within expiry and ongoing manufacturing.
Process validation evaluates the soundness of design and state of control of a process throughout its lifecycle. Each significant stage of a manufacturing process must be designed appropriately and assure the quality of raw material inputs, in-process materials, and finished drugs. Process qualification studies include intensive monitoring and testing throughout each significant process stage to characterize intra-batch variation and evaluate batches to determine whether an initial state of control has been established.
Successful process qualification studies are necessary before commercial distribution. Thereafter, ongoing vigilant oversight of process performance and drug product quality is necessary to ensure you maintain a stable manufacturing operation throughout the drug product lifecycle. See FDA’s guidance for industry,
Process Validation: General Principles and Practices
, for general principles and approaches that the FDA considers appropriate elements of process validation at
https://www.fda.gov/media/71021/download.
In response to this letter, provide:
A detailed summary of your validation program for ensuring a state of control throughout the product lifecycle, along with associated procedures. Describe your program for process performance qualification and ongoing monitoring of both intra-batch and inter-batch variation to ensure a continuing state of control.
A timeline for performing process performance qualification for each of your marketed drug products.
Process performance protocols, and written procedures for qualification of equipment and facilities.
A detailed program for designing, validating, maintaining, controlling, and monitoring each of your manufacturing processes that includes vigilant monitoring of intra-batch and inter-batch variation to ensure an ongoing state of control. Also, include your program for qualification of your equipment and facility.
Drug Recall
On May 13, 2026, FDA held a teleconference with you recommending you consider removing batches of all
(b)(4)
currently in distribution from the U.S. market.
On June 2, 2026, you issued a voluntary recall of all
(b)(4)
, and
(b)(4)
due to due to systemic quality failures at your facility. To date, you have not recalled your
(b)(4)
drug products.
CGMP Consultant Recommended
Based upon the nature of the violations we identified at your firm, you should engage a consultant qualified to evaluate your operations and to assist your firm in meeting CGMP requirements if your firm intends to resume manufacturing drugs for the U.S. market. The qualified consultant should also perform a comprehensive six-system audit of your entire operation for CGMP compliance and evaluate the completion and efficacy of your corrective actions and preventive actions before you pursue resolution of your firm’s compliance status with FDA.
Your use of a consultant does not relieve your firm’s obligation to comply with CGMP. Your firm’s executive management remains responsible for resolving all deficiencies and systemic flaws to ensure ongoing CGMP compliance.
Conclusion
The violations cited in this letter are not intended to be an all-inclusive list of violations that exist at your facility. You are responsible for investigating and determining the causes of any violations and for preventing their recurrence or the occurrence of other violations.
FDA placed all drugs and drug products offered for import into the United States from your firm on Import Alert 66-40 on June 5, 2026.
Correct any violations promptly. FDA may withhold approval of new applications or supplements listing your firm as a drug manufacturer until any violations are completely addressed and we confirm your compliance with CGMP. We may re-inspect to verify that you have completed corrective actions to any violations.
Failure to address any violations may also result in the FDA continuing to refuse admission of articles manufactured at Dabur India Limited, at Survey No. 225/4/1, Village: Saily, Silvassa, Dadra and Nagar Haveli and Daman and Diu, into the United States under section 801(a)(3) of the FD&C Act, 21 U.S.C. 381(a)(3). Articles under this authority that appear to be adulterated may be detained or refused admission, in that the methods and controls used in their manufacture do not appear to conform to CGMP within the meaning of section 501(a)(2)(B) of the FD&C Act, 21 U.S.C. 351(a)(2)(B).
This letter notifies you of our findings and provides you an opportunity to address the above deficiencies. After you receive this letter, respond to this office in writing within 15 working days. Specify what you have done to address any violations and to prevent their recurrence. In response to this letter, you may provide additional information for our consideration as we continue to assess your activities and practices. If you cannot complete corrective actions within 15 working days, state your reasons for delay and your schedule for completion.
Send your electronic reply to CDER-OC-OMQ-Communications@fda.hhs.gov. Identify your response with FEI 3001413302 and ATTN: Rokhsana Safaai-Jazi.
Sincerely,
/S/
Francis Godwin
Director
Office of Manufacturing Quality
Office of Compliance
Center for Drug Evaluation and Research
Content current as of:
08/04/2026
Regulated Product(s)
Drugs
Over-the-Counter Drugs