Reliance Life Sciences Private Limited MARCS-CMS 730801 — August 18, 2026

WARNING LETTER

---

• Delivery Method: VIA ELECTRONIC MAIL READ/DELIVERY RECEIPT REQUESTED
• Reference #: 320-26-117
• Product: Drugs

---

• Recipient: Mr. Santhosh Mathai; Business Head-Pharmaceuticals; Reliance Life Sciences Private Limited; Dhirubhai Ambani Life Sciences Centre; R-282 Ttc Area of MIDC, Thane Belapur Road, Rabale; Navi Mumbai 400701; Maharashtra; India; (b)(6)

• Issuing Office: Center for Drug Evaluation and Research (CDER); United States

---

August 18, 2026

WARNING LETTER
Reference number: 320-26-117

To Mr. Santhosh Mathai:

This warning letter advises you of significant violations observed during a U.S. Food and Drug Administration (FDA) inspection of your facility. Promptly address the violations described herein without delay, including ensuring that appropriate resources are allocated to fully address the violations and prevent their recurrence. This is not intended to be an all-inclusive list of the violations that exist at your facility. It is your responsibility to ensure that your firm complies with all requirements of federal law, including FDA regulations. Failure to adequately address violations may result in regulatory action without further notice.

FDA Inspection

Violations were observed and documented during an inspection of your drug manufacturing facility, Reliance Life Sciences Private Limited, FDA Establishment Identifier (FEI) 3009510975, at Dhirubhai Ambani Life Sciences Centre, R-282 Ttc Area Of MIDC, Thane Belapur Road, Rabale, Navi Mumbai, Maharashtra, 400701 India, from February 19 to February 27, 2026. This inspection was conducted under FDA’s statutory authority and public health responsibilities to protect the public from unsafe, ineffective, and poor quality drugs.

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 March 20, 2026, response to our Form FDA 483 in detail and acknowledge receipt of your subsequent correspondence.

Violations of the Federal Food, Drug, and Cosmetic Act

The following are violations identified during our inspection. As a reminder, this is not an all-inclusive list of violations at your facility.

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)).

Inaccurate Microbiology Laboratory Records

You failed to accurately document microbiology testing results. Specifically, multiple environmental monitoring and (b)(4) samples were documented in logbooks as collected and incubated; however, the corresponding plates could not be located in incubators during the inspection. Colony forming unit (cfus) counts had been recorded as if incubation was actively in progress. In interviews conducted by your management, your analysts confirmed these samples were not collected.

In addition, your Laboratory Information Management System (LIMS) did not include a dilution factor to calculate the number of cfus per gram or milliliter of product for microbial limit test results, as required by your own procedures and applicable compendial methods. By releasing drug products based solely on raw plate count averages entered into your LIMS without applying the required dilution factor, you lack scientific evidence that each batch conforms to predetermined specifications prior to distribution. Appropriate testing is an essential part of ensuring that the drug products you manufacture conform to CGMP.

Collectively, these deficiencies indicate a significant risk of systematic underreporting of microbial findings, which directly undermines your firm's ability to ensure the safety and quality of drug products distributed to patients.

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 quality unit (QU) to exercise its function of ensuring compliance to applicable standards and deprives you of the ability to adequately investigate deviations.

Inadequate Electronic Records Controls

Your firm did not have adequate controls to prevent the deletion or overwriting of (b)(4) integrity testing electronic data. Specifically, reports were not saved with unique file names, resulting in data being overwritten after every (b)(4) tests. In addition, (b)(4) integrity testing was not performed for Plant (b)(4). Therefore, your firm has no means of tracking or retrieving records of failed leak tests. The lack of adequate electronic records controls undermines the reliability and integrity of your laboratory data.

(b)(4) integrity is critical to preventing product contamination. Routine (b)(4) integrity tests should be performed. The monitoring and maintenance program should identify and eliminate any (b)(4) lacking integrity and minimize the possibility of placing a sterile product at risk.

All data must be complete, accurate and retained to enable appropriate assessment and decisions by the QU. The lack of control over the integrity of your data raises questions about the authenticity and reliability of your analytical data and the quality of your drug products.

Your response states “the unaccounted samples may have been misplaced”. This explanation is contradictory as it does not address the fact that your own analysts confirmed during management interviews that the microbiological samples were never collected, nor does it address the broader pattern of inaccurate recordkeeping identified during the inspection. Your response indicates your commitment to hiring third parties to conduct a data integrity remediation plan, risk assessment, and product impact assessment. Your response is inadequate. You do not provide sufficient detail including specific timelines and deliverables on your data integrity remediation plan, risk assessment and product assessment. Furthermore, your response does not define the scope of third-party oversight responsibilities or establish accountability measures for the remediation effort.

Additionally, you acknowledge deficiencies in your “(b)(4) integrity testing controls” and conducted a retrospective review. Your response is inadequate because although you conclude there is, “no evidence of product contamination attributable to (b)(4) failure”, the thoroughness of this review cannot fully support a definitive risk-based conclusion since you acknowledge that “historical traceability was incomplete”.

We acknowledge your firm’s long-term commitment to improving your manufacturing operation, including, but not limited to, hiring additional microbiological laboratory staff and building a larger microbiological laboratory.

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 acknowledge that you are using independent third-party consultants 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 lapses.
  o A comprehensive retrospective evaluation of the nature of the testing 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 retrospective review of all microbial limit test results to include the proper dilution factor to calculate the number of cfus per gram or milliliter of product for products currently in the U.S. market and within expiry as of the date of this letter and a report summarizing the findings of the analysis. Your action plan to address any product quality or patient safety risks for your drug products in U.S. distribution, including potential customer notifications and recalls.
• 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 (CAPA) 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 An indication of whether you plan to hire a data 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.
• A comprehensive 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 attributable, legible, complete, original, accurate, contemporaneous (ALCOA) records throughout your operation.
• 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.
• An action plan and timelines for conducting full microbiological testing of reserve samples to determine the quality of all batches of drug product distributed to the United States that are within expiry as of the date of this letter.
• 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.
• A detailed risk assessment addressing the hazards posed by distributing drug products with potentially objectionable contamination. Specify actions you will take in response to the risk assessment, such as customer notifications and product recalls.
• Complete investigations into all batches with potential objectionable microbial contamination. The investigations should detail your findings regarding the root causes of the contamination.
• 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, the following:
  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 establish and 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)).

Poor Aseptic Practices

Our inspection identified aseptic processing design deficiencies that pose significant hazards to drug product sterility. During a mock filling operation and during review of your unidirectional smoke studies, our investigators observed multiple instances of inappropriate aseptic behavior in which operators blocked unidirectional airflow at critical locations without implementing appropriate corrective measures, including discarding potentially compromised vials. Specific examples include:

• Blocking airflow over the stopper bowl and (b)(4) vials while refilling the stopper bowl
• Passing forceps over the (b)(4) and removing fallen vials from the (b)(4) and (b)(4) over (b)(4) vials
• Blocking airflow during (b)(4) transfer operations, including (b)(4) repositioning of filled vials onto a (b)(4) and mechanical displacement of (b)(4) vials into the (b)(4) via forceps

Any compromise of first-air protection exposes sterile drug products to potential microbiological contamination.

Cleaning, Decontamination, and Maintenance

You failed to adequately clean, decontaminate, and maintain your (b)(4) used for aseptic drug product manufacturing. For example, our investigator observed multiple instances of deterioration and damage inside the (b)(4) used for manufacturing sterile drug products. These instances of deterioration and damage were not adequately addressed through your cleaning, decontamination, and maintenance programs. For example, our investigator observed:

• Deteriorated (b)(4) used to support the (b)(4) tank
• Excess sealant adjacent to the HEPA filters in the filling and (b)(4) areas
• Use of nonsterile wipes soaked in (b)(4) to clean (b)(4)

In addition, our investigator observed accumulation of standing water and unknown (b)(4) staining on the wall surface adjacent to the (b)(4) pipelines, located outside the (b)(4) room within the HVAC area.

All equipment and associated operational areas should follow a reliable, comprehensive preventive maintenance program. This program should be designed to ensure sustained operational integrity through the systematic implementation of validated cleaning and disinfection protocols, as well as the proactive replacement of components before they deteriorate or degrade. Maintenance and change management procedures should prevent practices that may compromise equipment or introduce contamination risks.

Aseptic processes need to be designed to minimize exposure of sterile articles to potential contamination hazards. A suitable monitoring system is critical to maintain appropriate environmental conditions throughout your (b)(4) and cleanrooms. Prompt detection of an emerging problem is essential to preventing contamination of your aseptic production operations.

Your response states existing procedures "did not adequately define acceptable hand positioning, intervention speed, first-air protection requirements, rejection criteria for potentially affected exposed units, or required actions following airflow interruption" and acknowledges “equipment design and ergonomic limitations within the (b)(4)”. Additionally, you state you will not resume operations until “successful aseptic process simulation run incorporating all listed interventions under worst-case conditions are completed”. Furthermore, you commit to updating procedures for (b)(4) sanitization and cleaning to include sterile (b)(4) and sterile wipes. Your response also states that remediations were made to equipment, including repairing all sealant joints in the (b)(4), smoothing internal machine surfaces to meet cleanability requirements, and updating maintenance checklists to include criteria for wear, damage, smoothness, cleanability, and material suitability.

Your response is inadequate. You do not provide sufficient detail including deliverables on your third-party risk assessment of all aseptic filling lines. Additionally, your response does not sufficiently address the lack of oversight of operator aseptic behavior, equipment cleaning and maintenance, various manual activities, and intervention ergonomics.

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/media/71026/download.

In your response to this letter, provide the following:

• 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.
• A CAPA plan, based on the retrospective assessment of your cleaning and disinfection program, that includes appropriate remediations to your cleaning and disinfection processes and practices, and timelines for completion. Provide a detailed summary of vulnerabilities in your process for lifecycle management of equipment cleaning and disinfection. Describe improvements to your cleaning and disinfection program, including enhancements to cleaning effectiveness; improved ongoing verification of proper cleaning and disinfection execution for all products and equipment; and all other needed remediations.
• A comprehensive, independent risk assessment by a qualified consultant of all contamination hazards with respect to your aseptic processes, equipment, and facilities, including, but not limited to, the following:
  o All human interactions within the ISO 5 area (e.g., risk reduction or elimination of manual interventions wherever possible).
  o Equipment suitability (e.g., reliability, capability, ergonomics, placement) and sufficient cleanroom space.
  o Personnel Flow and Material Flow (movement throughout all rooms used to conduct and support sterile operations, and all material transfers).
  o Specific CAPA recommendations that will comprehensively address the design and control hazards identified in the risk assessment.
• A detailed remediation plan from the independent consultant 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, the specific barrier system to be used (e.g., Restricted Access Barrier, (b)(4)), and associated timelines. Also, describe your plans for qualification and validation of your extensively remediated operations.

Ineffective 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 and laboratory operations, we found your quality unit is not enabled to exercise proper authority and/or has insufficiently implemented its responsibilities. Executive management should immediately and comprehensively assess your company’s global manufacturing operations to ensure that your systems, processes, and products conform to FDA requirements.

Drug Recall and Drug Production Suspended

On June 18, 2026, FDA held a teleconference with you recommending you consider removing any batches of sterile drugs currently in distribution from the U.S. market. On June 19, 2026, you agreed to recall all sterile drug products.

We acknowledge your commitment to suspend production of all drugs at this facility for the U.S. market.

You are responsible for resolving all deficiencies and systemic flaws to ensure your firm is capable of ongoing CGMP compliance prior to resumption of any manufacturing operations. In addition, 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 assist your firm in meeting CGMP requirements. 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 all CAPA, before you pursue resolution of your firm’s compliance status with FDA.

In your notification to the Agency, provide a summary of your remediations to demonstrate that you have appropriately completed all CAPA.

Conclusion

You are responsible for investigating and determining the root causes of any violations and implementing corrective and preventative measures to ensure future and sustained compliance so that these violations and any others do not occur.

FDA placed all drugs and drug products offered for import into the United States from your firm on Import Alert 66-40 on July 9, 2026.

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 Reliance Life Sciences Private Limited, Navi Mumbai, 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).

Send your written response to CDER-OC-OMQ-Communications@fda.hhs.gov within fifteen (15) business days of receipt of this letter¹. Identify your written response with FEI 3009510975 and ATTN: Claire Minden in the letter or in the subject line of the email.

If you have information that you believe demonstrates that your products are not in violation of the FD&C Act and FDA regulations, include that information for our consideration.

If you are considering an action that is likely to lead to a disruption in the supply of drugs produced at your facility, FDA requests that you contact CDER’s Drug Shortages Staff immediately, at drugshortages@fda.hhs.gov, so that FDA can work with you on the most effective way to bring your operations into compliance with the law. Contacting the Drug Shortages Staff also allows you to meet any obligations you may have to report discontinuances or interruptions in your drug manufacture under 21 U.S.C. 356C(b). This also allows FDA to consider, as soon as possible, what actions, if any, may be needed to avoid shortages and protect the health of patients who depend on your products.

FDA posts warning letters on www.FDA.gov.

Sincerely,
/S/

Francis Godwin
Director
Office of Manufacturing Quality
Office of Compliance
Center for Drug Evaluation and Research
U.S. Food and Drug Administration

cc: Dr. Sandhya Narasimhan
usagent1@masuuglobal.com

___________________________

1 Under program enhancements for the Generic Drug User Fee Amendments (GDUFA) reauthorization for fiscal years (FYs) 2023-2027, also known as the GDUFA III Commitment Letter, your facility may be eligible for a Post-Warning Letter Meeting to obtain preliminary feedback from FDA on the adequacy and completeness of your corrective action plans.