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  1. Warning Letters

WARNING LETTER

Intas Pharmaceuticals Limited MARCS-CMS 721151 —

Delivery Method:
VIA EMAIL WITH READ RECEIPT
Reference #:
320-26-57
Product:
Drugs
Recipient:
Recipient Name
Mr. Kirti Maheshwari
Recipient Title
Chief Operating Officer
Intas Pharmaceuticals Limited

Plot No. 255, Magnet Corporate Park
Nr. Sola Bridge, S. G. Highway, Thaltej
Ahmedabad
India

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

United States

Warning Letter 320-26-57

March 30, 2026

Dear Mr. Maheshwari:

The United States Food and Drug Administration (FDA) inspected your drug manufacturing facility, Intas Pharmaceuticals Limited, FEI 3005890633, located at Camp Road, Selaqui, Dehradun, from September 8 to 17, 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 October 8, 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 thoroughly investigate any unexplained discrepancy or failure of a batch or any of its components to meet any of its specifications, whether or not the batch has already been distributed (21 CFR 211.192).

Your investigations into out-of-specification (OOS) assay results were inadequate. Your corrective and preventive actions (CAPAs) to address your persistent OOS assay results for (b)(4) tablets were not robust, as evidenced by the continued trend of subpotent assay stability failures and multiple (b)(4) to drug product expiry period.

For example, since 2023, your testing has shown multiple confirmed stability OOS results for (b)(4) batches. You (b)(4) your expiry period from (b)(4) to (b)(4), and then further (b)(4) it to the current (b)(4). We acknowledge your decision to recall (b)(4) batches of (b)(4) tablets in response to stability OOS results since 2024.

Multiple CAPAs included changes to batch processing to prevent further degradation of the active pharmaceutical ingredient. You also implemented modifications to your assay sample preparation procedures. However, you still experienced OOS assay results. For example, you tested 12-month long term stability batch (b)(4) and had a confirmed OOS result of (b)(4)% (specification is (b)(4)%). Your investigation of this 12-month stability failure was inadequate.

You identified the root cause as “product behavior” and recalled this batch. You did not adequately evaluate the reserves of all distributed batches or reserve batches using the same API lot to determine if market action is warranted, as required.

After the initial OOS result, you proceeded to test samples from the same batch and other previously OOS batches, using a revised analytical method with a different sample preparation and obtained different results. Despite using the revised analytical method, two batches ((b)(4) and (b)(4), (b)(4) tablets USP (b)(4) mcg and (b)(4) mcg) remained out of specification. Your investigation failed to evaluate why these batches still failed or assess whether the analytical method itself contributes to result variability. Attributing a failure to inherent drug product behaviors is not scientifically sound when a change in the test method yields a different outcome.

Additionally, after you implemented your revised method in July 2025 you continued to experience low assay results. For example, you invalidated an assay result of (b)(4)% for a sample batch ((b)(4)) used as a control due to “solution preparation error” without conclusive supporting evidence, despite the sample preparation analysis being deemed “satisfactory” during the laboratory Phase I investigation. You did not issue a CAPA plan for analyst training. You also discarded the initial OOS with insufficient supporting documentation and did not include it in your final reporting of the assay result.

In your response, you attribute the low assay values to the analytical limitation in the assay method, specifically incomplete extraction of the active pharmaceutical ingredient. You state it is not “totally due to actual product degradation.” You discuss your submission of a (b)(4) to the Agency to address the assay OOS results. Using the revised method, your new assay results appeared to be closer to the lower specification end. The variability in the new results does not clearly explain why these results are outside of the target assay value.

Additionally, you initiated testing of all (b)(4) distributed batches of (b)(4) tablets USP (all strengths) within their approved shelf-life for the U.S. market. All batches met the specification criteria.

Your response is inadequate. Your response does not address why the extraction limitation was not identified during the original method validation or explain what failures in your method validation process allowed this critical deficiency. In addition, your impact assessment of the evaluation of the extraction method did not extend to all assay values specifically which were on the higher end of the specification. Your response does not review or correlate market complaints or adverse events with low assay batches, which would be critical for a patient safety assessment.

In response to this letter, provide the following:

  • An impact assessment of (b)(4) tablet batches within expiry that showed assay results below your target assay. This assessment can coincide with your protocol for impact assessment for batches in the U.S. market that have stability testing assay results below (b)(4)%. Identify any common variables leading to the low assay values. Provide the OOS investigations for batch (b)(4) and all OOS assay failures for (b)(4) tablets since the FDA inspection.
  • An assessment of each drug product process to ensure that there is a data-driven and scientifically sound program that identifies and controls all sources of variability, such that your production processes, and will consistently meet appropriate specifications and manufacturing standards. This includes, but is not limited to, evaluating suitability of equipment for its intended use, sufficiency of detectability in your monitoring and testing systems, quality of input materials, and reliability of each manufacturing process step and 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 assurance oversight, and written procedures. Address how your firm will ensure all phases of investigations are appropriately conducted.
  • An independent third-party 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 when needed, implements final quality assurance decisions, and is fully supported by executive management.

2. Your firm’s quality control unit failed to exercise its responsibility to ensure drug products manufactured are in compliance with CGMP and meet established specifications for identity, strength, quality, and purity (21 CFR 211.22).

Your firm lacks controls to assure the integrity of electronic batch record data. Your quality assurance employee instructed your software vendor to make changes to your electronic batch record which were not captured in the audit trail or managed through your quality system.

During the inspection, you provided written communication from a quality assurance employee to the software vendor that discussed multiple changes and modifications made to the electronic batch record. One of the changes included the replacement of an employee identification number with another employee number for “Dispensed by” in (b)(4) tablets USP (b)(4) mcg batch record (b)(4). The change was not recorded in the audit trail, nor was it noted in the electronic batch record. Additionally, your firm lacked detailed procedural controls to assure the integrity of electronic batch record data when modifications are made after completion of the batch record.

In your response, you indicate that the changes the software vendor made in the electronic batch record corrected inaccuracies only. You state your requests to software vendors to modify data have been terminated. You commit to conducting formal interviews with employees who contacted the vendors to request the data changes and to initiating deviation investigations. You commit to performing a retrospective review of all group and individual email messages sent to the software vendor to determine which email messages contained CGMP instructions. You also commit to conducting a review of the audit trails of all U.S. batches.

Your response is inadequate. You fail to provide documentation of the deviations, interview transcripts, or discussion held with the employees who requested changes to electronic batch record data. You fail to explain why Quality Assurance did not initiate a deviation upon finding discrepancies or why the batch record contained no comments or remarks about the employee identification change. Additionally, your retrospective review of email requests to software vendors for data changes did not include an assessment of communications with other software vendors such as (b)(4).

In response to this letter, provide the following:

  • A retrospective review of all software related communications and correlated audit trail between your Intas Dehradun facility and software support vendors. Provide any updated deviations and related CAPA reports.
  • A product impact assessment for identified communications related to changes in batch record data and process parameters.
  • Effectiveness checks for the CAPAs implemented in your “Data Integrity Risk Assessment” of software applications, conducted by third party consultants in 2024.
  • Performance qualification deviations for your (b)(4) filling machine ((b)(4), Model (b)(4), equipment ID: DP-38). Include a report discussing the discrepancies in entries in the data sheet versus audit trail data, including maximum (b)(4). This equipment is related to a (b)(4) for (b)(4) solution (b)(4).
  • 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
    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 manufacturing/quality issues and to assure a continuing state of control.

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.

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.

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 refusing admission of articles manufactured at Intas Pharmaceuticals Limited located at Camp Road, Selaqui, Dehradun, 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 days1. 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 3005890633 and ATTN: Erika V. Butler.

Sincerely,
/S/

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

________________

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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