BioMylz Pvt. Ltd.

The United States Food and Drug Administration (FDA) inspected your drug manufacturing facility, BioMylz Pvt. Ltd., FEI 3013697420, at #21 - D #21 - D Building No 1, Bengaluru, Karnataka, India, from February 4 to 9, 2026.

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).

In addition, violations were identified and documented during a review of your firm’s drug listing submissions in FDA’s electronic Drug Registration and Listing System (eDRLS). Based on our review, you failed to provide complete drug listing information for your Soraresal Cream, NDC 73526-002, and Equate Medicated Vaporizing Steam Liquid, NDC 73559-011, as required under section 510(j) of the FD&C Act, 21 U.S.C. 360(j). Failure to provide complete listing information for a drug in accordance with 510(j) of the FD&C Act is prohibited under section 301(p) of the FD&C Act, 21 U.S.C. 331(p). Furthermore, these drugs are misbranded under section 502(o) of the FD&C Act, 21 U.S.C. 352(o). Introducing or delivering these products for introduction into interstate commerce is prohibited under section 301(a) of the FD&C Act, 21 U.S.C. 331(a). These violations are described in more detail below.

We reviewed your February 27, 2026, response to our Form FDA 483 in detail. Your response is inadequate because you failed to provide supporting documentation for evaluation or adequate evidence of corrective actions taken to bring your operations into compliance with CGMP.

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

1. 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).

You manufacture an over-the counter (OTC) drug product, a topical psoriasis cream, for the U.S market.

Your quality unit (QU) failed to ensure that all CGMP records were retained and available for review. Our investigators discovered a garbage bag containing original data. The recovered documents included, but were not limited to:

executed production batch records

media preparation

incubation and sterilization cycle logbook pages

finished product sample collection forms

environmental monitoring sample forms

product complaint and change control log forms

Additionally, your firm failed to maintain complete laboratory records, including original data for laboratory analyses conducted on commercial drug products. Specifically, you did not retain original data supporting laboratory test results used to release commercial batches, and you were not able to make this data available for FDA review.

Furthermore, you did not adequately control laboratory logbooks. Your logbooks had unnumbered pages and lacked reconciliation, and you did not permanently and contemporaneously document original data. For example, your personnel used a pencil to initially record volume entries and subsequently overwrote them in ink after completion of the weight check activity.

In your response, you attributed the torn documents to the actions of a former employee (ex-plant manager) who made false entries to intentionally increase yield. You also stated that this was an isolated and exceptional incident with no identified impact on approved or controlled documents and that the employee was terminated. However, your statement in the response is contradicted by the evidence provided to our investigators. This evidence indicates that the manager had been repeatedly observed on multiple occasions violating data integrity practices including, but not limited to, destruction of batch production records, destruction of laboratory-controlled records, and falsification of production and laboratory data.

Your response is inadequate. You did not address your egregious and persistent data integrity issues, nor did you provide any detailed or systemic remediations. You also did not conduct a comprehensive evaluation of the manufacturing and laboratory records to determine the impact of the data integrity breeches on the quality of your OTC drug products manufactured for the U.S. market.

All testing records and raw data must be handled appropriately and in accordance with established procedures. Your response fails to describe immediate corrective actions to prevent the alteration or destruction of CGMP data.

Your firm’s quality systems are inadequate. For help implementing quality systems and risk management approaches to meet the requirements of CGMP regulations 21 CFR, parts 210 and 211, see FDA’s guidance documents:• ICH Q10 Pharmaceutical Quality System at https://www.fda.gov/media/71553/download• Quality Systems Approach to Pharmaceutical CGMP Regulations 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: Questions and Answers for guidance on establishing and following CGMP compliant data integrity practices at https://www.fda.gov/media/119267/download.

Reliability of data is compromised when there is a failure to maintain complete records of the conditions and data associated with all tests and manufacturing activities. The lack of complete data compromises the ability of the QU to exercise its function of ensuring compliance to applicable standards.

We strongly recommend that you retain an independent qualified third-party consultant to assist in your remediation. In response to this letter, provide:

A comprehensive investigation into the extent of the inaccuracies and inconsistencies 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 deficiencies.o A comprehensive retrospective evaluation of the nature of the testing and manufacturing data integrity deficiencies. We recommend that a qualified third party with specific expertise in the area where potential breaches were identified should evaluate all occurrences.

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 event 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 each data integrity deviation, 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 the data integrity breaches 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 ensure the quality of your drugs and protect patients, such as notifying your customers, recalling product(s), 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.

2. Your firm failed to establish adequate written procedures for production and process control designed to assure that drug products you manufacture have the identity, strength, quality, and purity they purport or are represented to possess, and to follow all of your written production and process control procedures (21 CFR 211.100(a) and 211.100(b)).

You failed to demonstrate adequate validation of your manufacturing process. You were unable to demonstrate that your (b)(4) processes assure (b)(4) after commercial scale-up of your process. For example, critical control process parameters such as (b)(4) were not adequately documented in batch records. Furthermore, you did not conduct adequate in-process hold time studies and stability studies to support shelf life.

You also failed to adequately demonstrate the effectiveness of your cleaning procedures to ensure the removal of active pharmaceutical ingredient (API) residue, as well as control of potential microbial contamination from your shared manufacturing equipment after the scale-up.

Your response indicates that process and cleaning validation were performed in 2019 prior to the commercial scale-up, and you commit to performing process validation for the upcoming commercial orders. Additionally, you stated that cleaning validation studies, including residue limit calculations and worst-case assessments, have been conducted and documented. However, your response is inadequate. You lack supporting documentation for both activities, and you did not provide a timeline for completing the re-validation following commercial scale-up.

Process validation evaluates the soundness of design and state of control of a process throughout its lifecycle. Each significant stage of a manufacturing process must be designed appropriately and assure the quality of raw material inputs, in-process materials, and finished drug products.

Also, process qualification studies characterize intra-batch variation and evaluate batches to determine whether an initial state of control has been established. They include intensive monitoring and testing throughout each significant process stage (e.g., (b)(4)batch formulation and filling).

Successful process qualification studies are necessary before commercial distribution. Thereafter, ongoing vigilant oversight of process performance and product quality is necessary to ensure you maintain a stable manufacturing operation throughout the product lifecycle. See FDA’s guidance for industry, Process Validation: General Principles and Practices, for general principles and approaches that the FDA considers appropriate elements of process validation at https://www.fda.gov/media/71021/download.

In response to this letter, provide:

A detailed summary of your validation program for ensuring a state of control throughout the product lifecycle, along with associated procedures. Describe your program for process performance qualification, and ongoing vigilant monitoring of both intra-batch and inter-batch variation to ensure a continuing state of control. Also, describe your equipment and facility qualification program.

A timeline for performing appropriate process performance qualification for each of your marketed drug products. Also provide a risk assessment and any follow-up actions to be taken for the distributed drug products produced prior to performing any process validation studies.

Process performance protocols, and written procedures for qualification of equipment and facilities.

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 toxicitieso drugs with higher drug potencieso drugs of lower solubility in their cleaning solventso drugs with characteristics that make their manufacturing equipment difficult to cleano swabbing locations for areas that are most difficult to cleano maximum hold times before cleaning

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

3. Your firm failed to establish laboratory controls that include scientifically sound and appropriate specifications, standards, sampling plans, and test procedures designed to assure that components, drug product containers, closures, in-process materials, labeling, and drug products conform to appropriate standards of identity, strength, quality, and purity (21 CFR 211.160(b)).

You failed to ensure components and drug products are adequately monitored for microbiological contamination. For example, your topical psoriasis cream does not include testing for the presence of objectionable microorganisms, such as Staphylococcus aureus and Pseudomonas aeruginosa, critical for cutaneous products.

In response to this letter, provide:

A list of chemical and microbial specifications, including test methods, used to analyze each lot of your drug products before a lot disposition decision.

An action plan and timelines for conducting full chemical and microbiological testing of retain 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 summary of all results obtained from testing retain samples from each batch. If such testing reveals substandard quality drug products, take rapid corrective actions, such as notifying customers and product recalls.

Based upon the nature of the violations we identified at your firm, we strongly recommend that your firm 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.

Drugs must be manufactured in conformance with CGMP. FDA is aware that many drug manufacturers use independent contractors such as production facilities, testing laboratories, packagers, and labelers. FDA regards contractors as extensions of the manufacturer.

You and your customer Atrimed Pharmaceuticals Private Limited have a quality agreement regarding the manufacture of the U.S. marketed Soraresal Cream OTC drug product.

You are responsible for the quality of drugs you produce as a contract facility regardless of agreements in place with product owners. You are required to ensure that drugs are made in accordance with section 501(a)(2)(B) of the FD&C Act to ensure safety, identity, strength, quality, and purity. See FDA’s guidance document Contract Manufacturing Arrangements for Drugs: Quality Agreements at https://www.fda.gov/media/86193/download.

Section 510(j) of the FD&C Act and 21 CFR Part 207 set forth the requirements for the listing of drugs. Under section 510(j)(1) of the FD&C Act and 21 CFR 207.49(a)(12), a registrant must provide the name and Unique Facility Identifier of every other establishment where manufacturing is performed for a drug and the type of operation performed at each such establishment. Under 21 CFR 207.1, “manufacture” includes manipulation, sampling, testing, or control procedures applied to the final product or to any part of the process, including, for example, analytical testing of drugs for another registered establishment’s drug. Upon review of your firm’s drug listings, it was found that you failed to include (b)(4) in your drug listing for Soraresal Cream, NDC 73526-002, and (b)(4) in your drug listing for Equate Medicated Vaporizing Steam Liquid, NDC 73559-011, as required by 21 CFR 207.49(a)(12). Failure to provide listing information for a drug in accordance with 510(j) of the FD&C Act is prohibited under section 301(p) of the FD&C Act.

Further, because (b)(4) performed release testing, which constitutes manufacturing under 21 CFR 207.1, they were required to be registered with FDA under 21 CFR 207.17(a). A search of eDRLS confirms that neither laboratory is registered with FDA. Accordingly, Soraresal Cream and Equate Medicated Vaporizing Steam Liquid were manufactured, in part, in establishments not duly registered with FDA. Under section 502(o) of the FD&C Act, a drug is misbranded if it was manufactured in an establishment not duly registered under section 510, or if it was not included in a list required by section 510(j). Under section 301(a), it is a prohibited act to introduce or deliver for introduction into interstate commerce any drug that is misbranded.

Complete, accurate, and up-to-date establishment registration and drug listing information is essential to promote and protect patient safety. FDA relies on establishment registration and drug listing information for several key programs, including drug establishment inspections, supply chain security, and post-market surveillance. Establishment registration and drug listing information is also widely used outside FDA for purposes such as electronic prescribing and electronic health records, insurance reimbursement, and patient education.

It is your responsibility to ensure that all drugs manufactured at your establishment comply with all establishment registration and drug listing requirements under section 510 of the FD&C Act, 21 U.S.C. 360, 21 CFR Part 207, and all other applicable FDA regulations. Registration and listing information and instructions on how to properly register an establishment or submit drug listings can be found at Electronic Drug Registration and Listing Instructions.

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.

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 BioMylz Pvt. Ltd., located at #21 - D #21 - D Building No 1, Bengaluru, Karnataka, 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 3013697420 and ATTN: Frank Wackes.