Wizcure Pharmaa Private Limited(320-26-97)

Issuing Office:

Center for Drug Evaluation and Research (CDER)

United States

Warning Letter 320-26-97

June 24, 2026

Dear Mr. Dange:

The United States Food and Drug Administration (FDA) inspected your drug manufacturing facility, Wizcure Pharmaa Private Limited, 3030304532, located at H-881, Phase III, RIICO Industrial Area Bhiwadi, Rajasthan, India, from December 3 to 10, 2025.

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 December 30, 2025, response to our Form FDA 483 in detail and acknowledge receipt of your subsequent correspondence.

During our inspection, our investigators observed specific violations including, but not limited to, the following.

1. 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)).

You lacked complete and original laboratory data demonstrating that the required testing was performed.

For example, our investigator observed (b)(4) personnel monitoring microbial plates in your laboratory incubator with visible microbial growth. The next day, our investigator observed microbial plates with the same identification information with no growth. Both management and a microbiologist confirmed that the original microbial plates were discarded and replaced with new plates. This false data misrepresented the ISO 5 environmental conditions of your aseptic processing line.

Additionally, our inspection found that you frequently failed to collect environmental monitoring, personnel monitoring, and (b)(4) samples, as required by your procedure. For example, personnel monitoring contact plates were not collected on November 29, 2025, during the manufacturing of (b)(4) solution USP (b)(4) batches (b)(4) and (b)(4).

We also identified critical discrepancies in your sample test results. We found that you failed to reliably incubate samples and record accurate microbial counts. For example, our inspection repeatedly found unreliable and incorrect microbiology data, including, but not limited to, environmental monitoring samples.

In addition, we identified other significant discrepancies in sample description, identification, and reconcilability. Our investigators also found laboratory forms were pre-filled with microbial testing information (e.g., sterility and (b)(4) testing results), further demonstrating untrustworthy documentation. Significantly, when your firm actually obtained environmental monitoring samples and we closely tracked the plates during our inspection, we noted several instances in which microbial contamination was present in your ISO 5 processing environment.

Our inspectional findings indicate serious recurring data integrity breaches in your laboratory relating to critical microbiological tests and monitoring.

Microbial monitoring and testing are essential quality control steps that are integral in preventing distribution of unsafe products. Such programs provide critical information on the state of control of the aseptic processing operation. Substitution of unreliable or false results fundamentally compromises a facility’s ability to identify risks to product sterility.

In your response, you acknowledge confirmation of these data integrity breaches based on interviews with personnel and review of documentation. Your firm suspended manufacturing and has initiated a protocol-driven remediation program. Your firm has also engaged an independent third-party consultant to help with a comprehensive investigation and identification of corrective actions and preventive actions (CAPA).

Your response is inadequate. While you acknowledge the systemic nature of your data integrity problems and have initiated an investigation, your response does not sufficiently address organizational causes of the observed data integrity practice. For example, you do not provide evidence that your quality unit organization has the resources and expertise to perform its function, including detecting deviations relating to data integrity and sterile drug operations.

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 for guidance on establishing and following CGMP compliant data integrity practices at https://www.fda.gov/regulatory-information/search-fda-guidance-documents/data-integrity-and-compliance-drug-cgmp-questions-and-answers.

In response to this letter, provide:

• A comprehensive, independent assessment of your laboratory practices, procedures, methods, equipment, documentation, and analyst competencies. Based on this review, provide a detailed plan to remediate and evaluate the effectiveness of your laboratory system.
• A comprehensive, independent assessment of documentation systems used throughout your manufacturing and laboratory operations to determine where documentation practices are insufficient. Include a detailed CAPA plan that comprehensively remediates your firm’s documentation practices to ensure you retain contemporaneous, attributable, legible, complete, original, and accurate records throughout your operation.
• 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 data integrity deviation and analyses of the risks posed by ongoing operations.
• A comprehensive CAPA, overseen by a qualified consultant, for handling microbiological sampling media to ensure robust and reliable data. Establish a system that ensures uninterrupted custody and full reconciliation of all microbiological samples including, but not limited to:
o unique labeling of each sample
o signatures of all staff who handle the sample
o complete tracking of sample integrity and custody
o date and time of each activity (e.g., sample collection, transport, delivery, incubation, removal from incubator)
o digital time-stamped photos of all plates
o signatures of personnel performing reading of microbial counts
o provisions for verifications and routine quality assurance oversight.
• An independent assessment and remediation plan for your CAPA program. Provide a report that evaluates whether the program includes effective root cause analysis, ensures CAPA effectiveness, analyzes investigations trends, improves the CAPA program whenever needed, ensures final quality unit decision authority, and is fully supported by executive management.
• An independent review of your microbial effectiveness testing program, including assuring that all multi-use products are evaluated using sound microbial effectiveness study protocols and that each formulation is suitable throughout its use period.

2. Your firm failed to perform operations within specifically defined areas of adequate size and to have separate or defined areas or such other control systems necessary to prevent contamination or mix-ups in aseptic processing areas (21 CFR 211.42(c)(10).

Your aseptic manufacturing filling line used to produce over-the-counter (OTC) sterile drug products is inadequate.

For example, the inspection documented that your filling line has no physical barrier separating and protecting your ISO 5 (Grade A) aseptic filling line from the surrounding ISO 7 (Grade B) room and its personnel. The absence of a physical barrier separating the ISO 5 (Grade A) filling zone from the ISO 7 (Grade B) surrounding environment creates an unacceptable risk to product sterility.

Furthermore, several equipment parts in direct contact with drug product, containers, and closures were not sterilized.

It is essential that the ISO 5 (Grade A) environment continuously maintains an extremely high level of air cleanliness to protect the exposed sterile drug product from contamination. Without proper physical separation, the integrity of the aseptic processing environment cannot be reliably maintained as air currents, personnel movement, and other variables in the less-controlled ISO 7 space can directly convey contamination into the ISO 5 zone.

In addition, to ensure sterility, it is imperative that only sterile equipment comes into direct contact with the sterile formulation, containers, and closures.

Your aseptic processing room also had inadequate space to accommodate appropriate ergonomics, personnel flow, and material flow. Our inspection also found that your processing equipment was in poor state of repair, as detailed later in this letter.

Finally, you lacked a meaningful environmental monitoring (e.g., critical surfaces, viable air) and personnel monitoring program for your aseptic processing line.

Aseptic manufacturing processes operations must be performed in specifically defined areas of adequate size and vigilantly monitored to promptly identify microbial hazards before there is a non-sterility consequence.

In your response, you commit to replacing your (b)(4) filling line with a restricted access barrier system (RABS) and implementing a comprehensive environmental monitoring program.

Your response is inadequate. Your response lacks a comprehensive evaluation of aseptic processing facility suitability, including but not limited to cleanroom design.

In response to this letter, provide:

• A comprehensive independent risk assessment of all contamination hazards with respect to your aseptic processes, equipment, and facilities, that includes, but is not limited to:
  o all human interactions within the ISO 5 area (e.g., risk reduction or elimination of manual interventions wherever possible)
  o equipment placement and suitability, including ergonomics for each human interaction and sufficient cleanroom space
  o air quality in the ISO 5 area and surrounding room including, but not limited to, air volume and flow
  o reduction or elimination of aseptic manipulations
  o facility layout
  o personnel flows and material flows throughout all rooms used to conduct and support sterile operations
  o specific CAPA recommendations that will comprehensively address the design and control hazards identified in the risk assessment

• A detailed remediation plan with timelines to address the findings of the contamination hazards risk assessment. Describe specific tangible improvements to be made to aseptic processing operation design and control at your facility and explain how this CAPA plan will robustly remediate your deficient sterile manufacturing operations. Include comprehensive changes to the design of both your aseptic processing lines and cleanrooms. Also, describe your plans for qualification and validation of your extensively remediated operations.

• An independent, comprehensive review of your environmental monitoring program to ensure vigilant, timely detection and response to potential product contamination hazards in your manufacturing environment. This assessment should include, but not be limited to:
  o establishing appropriate limits
  o sampling methods
  o sampling locations and frequencies
  o trend analysis
  o appropriate investigation of deviations and adverse trends
  o and a comprehensive CAPA plan based on the findings of the assessment.

• A comprehensive, independent assessment of the design and control of your firm’s manufacturing operations with a detailed and thorough review of all microbiological hazards.

• 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.

3. Your firm failed to follow appropriate written procedures that are designed to prevent microbiological contamination of drug products purporting to be sterile, and that include validation of all aseptic and sterilization processes (21 CFR 211.113(b)).

Your aseptic process simulations (media fills) were not sufficiently representative of commercial aseptic manufacturing operations. Also, batch records lacked documentation of all personnel present and interventions conducted during aseptic manufacturing.

Additionally, the airflow visualization (i.e., smoke studies) was not performed under dynamic conditions to assess the hazards posed by interventions into the aseptic processing line. Your static airflow visualization addressed areas surrounding filling room (b)(4). Notably, we also observed aseptic operator deviations including, but not limited to, wearing safety glasses with exposed skin during aseptic production.

In your response, you acknowledge that media fills did not sufficiently document operations and that previously executed media fills were not representative of aseptic processing conditions.

Your response is inadequate. You lack sufficient details regarding batch record improvements to document the type, quantity, and duration of interventions during commercial batch production as well as media fill simulations.

See FDA’s guidance document Sterile Drug Products Produced by Aseptic Processing—Current Good Manufacturing Practice to help you meet the CGMP requirements when manufacturing sterile drugs using aseptic processing at https://www.fda.gov/regulatory-information/search-fda-guidance-documents/sterile-drug-products-produced-aseptic-processing-current-good-manufacturing-practice.

In response to this letter, provide the following:

• Perform a critical evaluation of airflow unidirectionality in your aseptic process with the assistance of a qualified consultant. Ensure smoke studies are conducted under dynamic conditions with thorough and complete evaluations of aseptic processing line airflow unidirectionality including the impact of dynamic interactions and aseptic interventions. These thorough smoke studies should be performed after you remediate your aseptic operation and conducted using proper practices (e.g., neutrally buoyant media) to appropriately visualize airflow.

• Your plan to ensure appropriate aseptic practices and cleanroom behavior. Include steps to ensure routine and effective supervisory oversight for all production batches. Also describe the frequency of quality unit oversight (e.g., audit) during aseptic processing and its support operations.

• A comprehensive, independent assessment of the qualifications and competencies of operations and quality assurance management to conduct their job duties throughout your aseptic manufacturing operations.

• A comprehensive assessment and remediation plan to ensure your quality unit (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
  oversight and approval of investigations and discharging of all other QU duties to ensure identity, strength, quality, and purity of all products.

4. Your firm failed to clean, maintain, and, as appropriate for the nature of the drug, sanitize and/or sterilize equipment and utensils at appropriate intervals to prevent malfunctions or contamination that would alter the safety, identity, strength, quality, or purity of the drug product beyond the official or other established requirements (21 CFR 211.67(a)).

You failed to adequately maintain your manufacturing equipment. For example, your filling line was observed with apparent rust on the critical aseptic processing equipment, including the (b)(4).

Also, our investigators observed stains and apparent rust on the HEPA filters and their diffuser grids above the filling line.

We are concerned with your management’s lack of oversight of manufacturing operations that allowed insanitary equipment to be used in sterile drug manufacturing.

An effective equipment management program requires a proactive lifecycle approach with systematic monitoring, maintenance, and timely replacement to ensure continued process capability. Pharmaceutical quality systems must integrate equipment performance data, maintenance oversight, and risk assessment to drive timely CAPA.

In your response, you acknowledged the presence of what appeared to be rust and deterioration in the (b)(4) filling line. You attributed the root cause to a systematic gap in equipment lifecycle management. You indicate that you conducted an assessment and remediation of equipment.

Your response is inadequate. While you acknowledge the identified systemic gaps in equipment lifecycle management, your corrective action appears to include limited remediations. Also, you did not conduct a retrospective risk assessment for batches that were processed using equipment in unsuitable condition for manufacturing sterile drug products.

In response to this letter, provide the following:

• A remediation plan that better assures ongoing management oversight throughout the manufacturing lifecycle of all drug products. Provide a more data-driven and scientifically sound program that identifies sources of process variability and assures that manufacturing (including both production and packaging) operations meet appropriate parameters and quality standards. This includes, but is not limited to, evaluating suitability of equipment for its intended use, ensuring quality of input materials, determining the capability and reliability of each manufacturing process step and its controls, and vigilant ongoing monitoring of process performance and product quality.

• A summary of updated SOPs that ensure an appropriate program is in place for verification of equipment condition and validation of cleaning procedures for products, processes, and equipment.

• Provide a detailed remediation plan, performance protocols, and written procedures that include a defined timeline, milestones, and documentation to conduct the qualification of equipment (e.g., aseptic filling lines) and facilities (e.g., aseptic filling rooms).

Data Integrity Remediation

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/regulatory-information/search-fda-guidance-documents/data-integrity-and-compliance-drug-cgmp-questions-and-answers.

We acknowledge that you are using an independent third-party consultant to audit your operation and assist in meeting FDA requirements. 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 deviations.

  o A comprehensive retrospective evaluation of the nature of the testing/manufacturing/other 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 deviations.

• 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 data integrity deviations 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 data including analytical data, manufacturing records, and all data submitted to FDA.

  o A comprehensive description of the root causes of your data integrity deviations 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 deviations 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.

Drug Production Suspended

We acknowledge your commitment to suspend production of all (b)(4) OTC (b)(4) drug products for the U.S. market. In response to this letter, clarify whether you intend to resume manufacturing drugs for the U.S. market at this facility in the future.

If you plan to resume any manufacturing operations regulated under the FD&C Act, notify this office before resuming your drug manufacturing operations. You are responsible for resolving all deficiencies and systemic flaws to ensure your firm is capable of ongoing CGMP compliance. In your notification to the Agency, provide a summary of your remediations to demonstrate that you have appropriately completed all CAPAs.

Quality System

Significant findings in this letter demonstrate that your firm does not operate an effective quality system in accord with CGMP. In addition to the lack of effective management oversight of your production, laboratory operations, we found your quality unit is not enabled to exercise proper authority and has insufficiently implemented its responsibilities. Executive management should immediately and comprehensively assess your company’s operations to ensure that your systems, processes, and products conform to FDA requirements.

CGMP Consultant Recommended

Based upon the nature of the violations we identified at your firm, you should engage a consultant qualified as set forth in 21 CFR 211.34 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.

Drug Recall

On December 18, 2025, FDA held a teleconference with you recommending you remove any batches of (b)(4) OTC (b)(4) drug products and (b)(4) from the U.S. market.

On December 30, 2025, you communicated your commitment to cease manufacturing and distribution of all drugs for U.S. market. You also agreed to voluntary recall all drugs in current distribution in U.S.

On (b)(4), you issued a voluntary recall of all (b)(4).

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 December 23, 2025.

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 Wizcure Pharmaa Private Limited located at H-881, Phase III, RIICO Industrial Area Bhiwadi, Rajasthan, India, 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 3030304532 and ATTN: Rafael E. Arroyo.

Sincerely,
/S/

Francis Godwin
Director
Office of Manufacturing Quality
Office of Compliance
Center for Drug Evaluation and Research