Kenil Healthcare Private Limited - 704786 - 06/12/2025

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Warning Letter 320-25-81

June 12, 2025

Dear Mr. Patel:

The United States Food and Drug Administration (FDA) inspected your drug manufacturing facility, Kenil Healthcare Private Limited, FEI 3022380309, at Plot No. 319, Village Acharasan, Ankhol-Vamaj Road, Tal-Kadi, District Mehsana, Gujarat, from December 5 to 11, 2024.

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, 2024 response and subsequent correspondences 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 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 clean and maintain your filling rooms and tube filling equipment used to manufacture your (b)(4) and (b)(4) over-the-counter (OTC) drug products. For example, our investigators observed the following:

• The presence of mold and dirt on the walls in your filling and sealing rooms.
• Soiled and stained air handling units.
• Unidentified product buildup inside your (b)(4) manufacturing vessel and tube filling equipment.
• More than one drug product was found on the packaging line.

In addition, your firm did not have validated cleaning procedures, including written equipment usage and cleaning logs to demonstrate that your drug product manufacturing equipment was adequately cleaned and maintained.

In your response, you state that you revised your cleaning procedures and logbooks and commit to retrain your staff on cleaning practices and procedures. You also state that cleaning and sanitization of the filling and sealing rooms was conducted and building maintenance will be performed. Your response is inadequate because you failed to provide supporting data to demonstrate that your cleaning practices are sufficient to remove contaminants from the product surfaces of your drug product manufacturing equipment. You also failed to provide any documentation that the above-mentioned activities occurred. Furthermore, you failed to assess the impact of your inadequate cleaning processes on products that are currently on the market and within expiry.

It is essential that your facility and equipment are cleaned, and sanitary conditions are maintained, to ensure ongoing suitability for drug manufacturing, and to protect drug products from contamination.

In response to this letter, provide:

• 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 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 product.
• Your corrective action and preventive action (CAPA) plan to implement routine, vigilant operations management oversight of facilities and equipment. This plan should 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 program, that includes appropriate remediations to your cleaning processes and practices, and timelines for completion. Provide a detailed summary of vulnerabilities in your process for lifecycle management of equipment cleaning. Describe improvements to your cleaning program, including enhancements to cleaning effectiveness; improved ongoing verification of proper cleaning execution for all products and equipment; and all other needed remediations.
• 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 product.
• A summary of updated standard operating procedures that ensure an appropriate program is in place for verification and validation of cleaning procedures for products, processes, and equipment.
• Additional photographic evidence that demonstrates thorough cleaning of your filling and sealing areas, including but not limited to Rooms (b)(4) and (b)(4), and the completion of all necessary building maintenance in those areas.

2. Your firm failed to have buildings used in the manufacture, processing, packing, or holding of drug products with adequate space for the orderly placement of equipment and materials to prevent mix-ups and contamination (21 CFR 211.42(b)).

Your firm’s packaging and labeling operations are performed without adequate controls to prevent mix-ups and cross-contamination. For example, our investigators observed employees performing manual packaging and labeling operations on the floor of the manufacturing room. Investigators also noted that multiple drug products were packaged simultaneously without adequate separation and spacing. The drug products were also packaged without the use of batch records.

Our investigators also observed that your reserve samples were improperly stored, commingled with expired products, and lacked routine monitoring.

In your response, you state that you implemented procedures for dispensing and issuing packaging materials. Your response also includes plans to expand your warehouse. Your response is inadequate because you failed to address the interim plans to prevent labeling mixups in your current packaging area while you remediate your lack of adequate facility spacing. You also do not describe how you intend to ensure that the procedural updates are effective.

In response to this letter, provide:

• Your CAPA plan to improve packaging and labeling operations, including equipment and facility upgrades, effective preventive and corrective maintenance, enhanced performance monitoring, improved operations management oversight, and any other needed actions. Your CAPA plan should also assure the proper segregation and sufficient space for the orderly storage of samples.
• An action plan and timeline for conducting retrospective assessment of all your reserve samples in your sample storage area. Include supporting documentation to ensure that no product or package mix-ups have occurred, and any corrective actions, such as notifying customers of identified product mix-ups.

3. 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 quality unit (QU) did not provide adequate oversight for the manufacture of your drug products. For example, your QU failed to ensure the following:

• Review and approval of written procedures for production and process controls that are designed to assure the quality of your drug products, i.e., process validation (21 CFR 211.100(a)).
• Establishment of an adequate, ongoing stability program (21 CFR 211.166(a)).
• Adequate batch production and control records that include complete documentation of the accomplishment of each significant step in the manufacture, processing, packing, or holding of the batch, for each batch of drug product (21 CFR 211.188).
• Adequate review and approval of production and control records before a batch is released or distributed (21 CFR 211.192)
• Production and process control activities, such as equipment qualification, are documented at the time of performance (21 CFR 211.100(b)). Specifically, investigators observed your quality assurance manager generating and completing equipment qualification documents investigators previously requested. This practice raises concerns about the integrity and reliability of your firm’s data and documentation.

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.

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 Data Integrity and Compliance With Drug CGMP:
Questions and Answers | FDA

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 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 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 batches 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.
• 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.
• A comprehensive, independent assessment of your overall system for investigating deviations, discrepancies, complaints, out-of-specification 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, QU oversight, and written procedures. Address how your firm will ensure all phases of investigations are appropriately conducted.

Drug Recall

On March 26, 2025, FDA held a teleconference with you and your U.S. Agent, JMM Services LLC. We recommended that you recall all your drug products within expiry currently in distribution to the U.S. market. On April 9, 2025, your firm committed to recall the products within expiry. After several subsequent attempts were made to contact you and your registered U.S. Agent regarding the recall, you initiated the recall of all your drug products on April 24, 2025.

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. 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 CAPAs 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.

Cosmetics Manufactured for Distribution in the United States

In addition, some of the products you manufacture may be regulated as cosmetics, as defined in section 201(i) of the FD&C Act (21 U.S.C. 321(i)). Any cosmetics you manufacture must comply with applicable statutory and regulatory requirements, including the FD&C Act. A cosmetic is deemed adulterated under section 601(c) of the FD&C Act (21 U.S.C. 361(c)) if it has been prepared, packed, or held under insanitary conditions whereby it may have become contaminated with filth or whereby it may have been rendered injurious to health. Some conditions that cause the drug products you manufacture to be adulterated may also cause any cosmetics you manufacture to be adulterated. We note that under section 301(a) of the FD&C Act (21 U.S.C. 331(a)), it is a prohibited act to introduce or deliver for introduction into interstate commerce a cosmetic that is adulterated. Further, your facility may be subject to requirements under the Modernization of Cosmetics Regulation Act of 2022 (MoCRA). You may find the FD&C Act, MoCRA, and FDA’s regulations through links on FDA’s website at www.fda.gov.

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 April 4, 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 Kenil Healthcare Private Limited, located at Plot No. 319, Village Acharasan, Ankhol-Vamaj Road Ta-Kadi, District Mehsana, Gujarat, 382715, 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 3022380309 and ATTN: Yvette Johnson.

Sincerely,
/S/

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

Cc: Registered U.S. Agent
Ms. Julia Moffitt, JMM Services
Email: julia@jmm.one; Info@jmm.one