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  1. Warning Letters

WARNING LETTER

Auriga Research Pvt. Ltd. MARCS-CMS 730694 —

Delivery Method:
VIA UNITED PARCEL SERVICE
Reference #:
320-26-113
Product:
Drugs
Recipient:
Recipient Name
Dr. Saurabh Arora
Recipient Title
Managing Director and CEO
Auriga Research Pvt. Ltd.

3/17 Kirti Nagar, Industrial Area
New Delhi 110015
India

(b)(4)
Issuing Office:
Center for Drug Evaluation and Research (CDER)

United States

August 12, 2026

WARNING LETTER
Reference number: 320-26-113

To Dr. Saurabh Arora:

This warning letter advises you of significant violations observed during a U.S. Food and Drug Administration (FDA) inspection of your contract testing laboratory. 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 contract testing laboratory, Auriga Research Pvt. Ltd., FEI 3019975128, at No. 136, 6th Cross, 2nd Stage, Yeshwanthpur Industrial Suburb, Bengaluru, India, from February 4 to 6, 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, drug products you tested 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 27, 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 and review. 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)).

Your firm is a contract testing laboratory that conducts testing of various application and nonapplication drug products for the US market. Your laboratory records lacked complete and original data demonstrating that you performed the required testing.

You did not accurately complete laboratory records contemporaneously at the time you performed the laboratory activities. Our investigator observed (b)(4) microbial test samples that lacked complete documentation on raw data test sheets (e.g., the test sheets had blank spaces where entries should have been recorded). While your summary reports included final plate counts, your raw data test sheets for some of the samples covered in these reports lacked complete documentation of plate counts.

In your response, you stated these samples were not from drug products intended for the U.S. market. However, your firm maintains one quality system and has one set of procedures for testing U.S. and non-U.S. drug products. Thus, the quality unit (QU) failure is applicable to all drug products you test. Additionally in your response, you identify the documentation deficiencies to be “consistent with an institutional procedural and cultural gap rather than individual misconduct or a coordinated effort to conceal or falsify results.” This indicates that these violative practices are used for all drugs you test, including those for the U.S. market.

We acknowledge that your response indicated you will increase the QU presence during testing until procedural improvements, training effectiveness verification, and compliance monitoring demonstrate sustained adherence. Your response is inadequate because it does not include an assessment of your paper-based documentation system to identify and correct vulnerabilities in your current controls. Additionally, you did not provide evidence that you performed a retrospective review to identify any additional instances of incomplete or non-contemporaneous documentation.

Microbial testing, an essential quality control step, is integral in preventing distribution of unsafe products. Integrity of data is fundamentally compromised when there is a failure to record or maintain complete and accurate records of test results or conditions associated with drug testing. Furthermore, the lack of reliable data compromises the QU’s ability to exercise its function of ensuring compliance with 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 for guidance on establishing and following CGMP compliant data integrity practices at https://www.fda.gov/media/119267/download.

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 assessment of documentation systems used throughout your 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 (ALCOA) records throughout your operation.
  • 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, 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.

2. Your firm failed to establish adequate written responsibilities and procedures applicable to the quality control unit (21 CFR 211.22(d)).

Your QU is inadequate as demonstrated through its oversight of investigations. Your QU reviewed and approved investigations that did not thoroughly investigate unexplained discrepancies or failures of a drug product to meet any of its specifications. For example, your QU failed to adequately ensure root causes were appropriately supported and CAPA were justified and implemented for the following:

  • Concerning an out-of-specification (OOS) investigation for assay of (b)(4), after failing the initial test, hypothesis and two repeat tests, you changed your autotitrator instrument and reported passing results. You failed to scientifically justify the root cause, electrode sensing issue, and your investigation failed to include a CAPA.
  • Concerning an OOS investigation for assay of (b)(4) after failing the initial test, hypothesis, and five repeat tests, you invalidated all these results. You failed to scientifically justify the root cause, which you attributed as a sample weighing error and insufficient electrode saturation. Your preventive action was inadequate as you only verbally made “concerned analysts” aware.
  • Concerning an OOS investigation for a specified impurity, (b)(4), in stability samples, you accepted passing results by testing retain samples in triplicate. You failed to scientifically justify the root cause, which you attributed as contamination of the “MS source.” Your preventive action was inadequate as you only instructed the analyst to clean the source before the initiation of the analysis without revising your procedure.

This strategy of using repeated testing until you obtain a passing result, then disregarding the OOS results without scientific justification (“testing into compliance”) is unscientific and objectionable under CGMP.

In your response, you state you are revising your OOS investigation procedure to mandate your hypothesis plan with scientific justification. Your response is inadequate because you are revising procedures without performing a gap analysis of your investigations. Additionally, you have failed to address the authority, responsibility, and competency of your QU which had reviewed and approved all your out-of-specification investigations.

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 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
    o Also describe how top management supports quality assurance and reliable operations including, but not limited to, timely provision of resources to proactively address emerging quality issues and to assure a continuing state of control.
  • A comprehensive, independent assessment of your overall system for investigating deviations, discrepancies, complaints, OOS results, and failures. Provide a detailed action plan to remediate this system. Your action plan should include, but not be limited to, significant improvements in investigation competencies, scope determination, root cause evaluation, CAPA effectiveness, quality unit oversight, and written procedures. Address how your firm will ensure all phases of investigations are appropriately conducted.
  • 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.
  • A retrospective, independent review of all OOS including in-process and release/stability testing) results for U.S. products irrespective of whether the batch was ultimately distributed in the U.S. for the last three years from the initial date of inspection and a report summarizing the findings of the analysis, including the following for each OOS:
    o Determine whether the scientific justification and evidence relating to the invalidated OOS result conclusively or inconclusively demonstrates causative laboratory error.
    o For investigations that conclusively establish laboratory root cause, provide rationale and ensure that all other laboratory methods vulnerable to the same or similar root cause are identified for remediation.
    o For all OOS results found by the retrospective review to have an inconclusive or no root cause identified in the laboratory, include a thorough review of production (e.g., batch manufacturing records, adequacy of the manufacturing steps, suitability of equipment/facilities, variability of raw materials, process capability, deviation history, complaint history, batch failure history).
    o Provide whether customers were notified of each OOS.

Responsibilities of a Contract Testing Lab

FDA considers contractors as extensions of the manufacturer’s own facility. Your failure to comply with CGMP may affect the quality, safety, and efficacy of the drugs you test for your clients. It is essential that you understand your responsibility to operate in full compliance with CGMP and that you inform all your customers of any out-of-specification results or significant problems encountered during the testing of these drugs.

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 assist your firm in meeting CGMP requirements.

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

As previously stated, 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 may withhold approval of new applications or supplements listing your firm as a drug testing facility 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 refusing admission of articles manufactured by your clients and tested at Auriga Research Private Limited, Bengaluru, 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 3019975128 and ATTN: Compliance Officer Barbara Wilimczyk-Macri 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. 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: RD2Rx, LLC
(b)(4)

_____________________________

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.

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