Umendra Life Sciences Private Limited

Your facility is registered with the United States Food and Drug Administration (FDA) as a manufacturer of over-the-counter (OTC) drug products. FDA has reviewed the records you submitted in response to our August 14, 2025 request for records and other information pursuant to section 704(a)(4) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) for your facility, Umendra Life Sciences Private Limited, FEI 3035187076, at New Survey No. 211, Village Account No. 170 Old Block / Survey No. 158, Bavla, Taulka Mauje, Amipura, Ahmedabad, Gujarat.

This warning letter summarizes significant violations of Current Good Manufacturing Practice (CGMP) regulations for finished pharmaceuticals. See Title 21 Code of Federal Regulations, parts 210 and 211 (21 CFR, parts 210 and 211).

Because your methods, facilities, or controls for manufacturing, processing, packing, or holding of drugs as described in your response to our 704(a)(4) request 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)).

Following review of records and other information provided pursuant to section 704(a)(4) of the FD&C Act, significant violations were observed including, but not limited to, the following:

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

Your firm manufactures OTC (b)(4) drug products labeled to contain the active ingredient (b)(4). This drug product is also labeled and formulated to contain the inactive ingredient talc. For one of the drug products, the formulation is composed of more than (b)(4)% talc. Both talc and asbestos are naturally occurring minerals that may be found in close proximity in the earth. Asbestos is a potential contaminant in talc and is a known human carcinogen when inhaled.1,2 Additionally, published scientific literature dating back to the 1960s has suggested a possible association between the use of (b)(4) containing talc in the (b)(4) area and the incidence of (b)(4), potentially linked to asbestos contamination of the talc.3 The (b)(4) you produce can be used on areas of the body which may be an exposure risk (e.g., inhalation or (b)(4) area). Your drug products are considered a higher-risk drugs as it pertains to patient safety regarding asbestos contamination of talc due to the risk of inadvertent inhalation or potential use in the (b)(4) area.

Your quality unit (QU) did not effectively exercise its responsibility to ensure the acceptability of your drug components. For example, your QU did not ensure that test procedures and specifications for talc are scientifically sound and appropriate (see 21 CFR 211.160(b)). In addition, you did not demonstrate that your firm’s QU has adequate oversight of your contract testing facility. Your QU approved and accepted talc for use in drug manufacturing without ensuring compliance with CGMP.

Your QU failed to assure that contract facilities are testing according to your procedures which require you to follow current United States Pharmacopeia (USP) specifications and that results are supported by sufficient information to provide an accurate determination of compliance. In particular, your QU did not adequately review or approve methods used by your contract laboratory, and review and approve data to ensure results are supported by accurate data.

The tests included in the specification were not performed according to current USP. You did not conduct testing using Atomic Absorption for Calcium and Assay Content of Magnesium as required by USP. For identification and asbestos testing conducted, the documentation does not fully support results reported. Current USP identification procedure acceptance criteria is “the IR spectrum of a (b)(4) of it exhibits maxima at (b)(4) ± (b)(4) cm–1, at (b)(4) ± (b)(4) cm–1, and at (b)(4) ± (b)(4) cm–1” and absence of asbestos procedure (b)(4) by Infrared (IR) Spectroscopy includes the evaluation of the presence of tremolite, chlorite and serpentines, through scale expansions of spectra at the required wavenumbers of (b)(4) cm-1, and in the range of (b)(4) cm-1 to (b)(4) cm-1. Your instrument reports for the identification spectroscopy report was from (b)(4) cm–1 to (b)(4) cm–1 and did not identify peak maxima wavenumbers as required in USP for the one identification test performed. For tests conducted for asbestos, data does not include expansion of spectra at the required wavenumber of (b)(4)cm-1 and the range of (b)(4) cm-1 to (b)(4) cm-1 was covered in by the spectral analysis. Your identification spectra does not evaluate for the presence of serpentines between wavenumbers (b)(4) cm–1 and (b)(4) cm–1.

Furthermore, your specifications for talc components did not include testing for multiple impurities (e.g., limits of (b)(4)) and lacks identification procedures (b)(4) and (b)(4). Your QU approved and accepted talc for use in drug manufacturing with deficient specifications.

Your QU is responsible for fully exercising its authority and responsibilities, including responsibility for approving or rejecting all procedures or specifications impacting the identity, strength, quality, and purity of the drug product. 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:

A determination of whether procedures used by your firm are robust and appropriate.

Provisions for QU oversight throughout your operations, including an evaluation of your contract facility qualification program, to evaluate adherence to appropriate practices.

Gap analysis for your approved specifications, test methods and laboratory practices against the USP, where applicable, for drug components (active and inactive) and those conducted at your contract facility. If notable differences are observed, provide an impact analysis and corrective actions, which may include retrospective testing.

Your firm has not demonstrated that you appropriately tested incoming talc drug components or validated and established the reliability of your component supplier’s test analyses at appropriate intervals for talc.

You provided records to demonstrate you had conducted identity testing pursuant to the applicable USP test to satisfy the requirements for identity testing in 211.84(d)(1) and (2), the testing does not conform to the current USP testing method, in that it is incomplete (i.e., lacks identification (b)(4)). A representative certificates of analysis (COA) indicated that the material supplied appears to be Indian Pharmacopeia (IP) grade and sufficient information was not submitted to support that materials meet USP monograph standards. Our review of the IP talc monograph revealed that the IP provides less details and lacks some critical requirements such as assay and several impurities (e.g., (b)(4)). Additionally, you relied on the COA from your suppliers and failed to establish the reliability of each of your suppliers’ COA for component specifications and characteristics at appropriate intervals. Although 21 CFR 211.84(d)(2) provides for some reliance on a COA from the supplier of the component, such reliance is permissible only if the drug product manufacturer establishes the reliability of the supplier’s test results through appropriate validation of the test results at appropriate intervals. Without adequate testing, you lack scientific evidence that the components conform to appropriate specifications prior to use in the manufacture of your drug products.

As a manufacturer, you have a responsibility to sample, test, and examine, as appropriate, drug components before use in production to ensure acceptable specifications for identity, strength, quality, and purity are met. Because you have not performed appropriate testing that detects asbestos in your talc components, among other things, you failed to assure the acceptability of these drug components for use in manufacture of your drug products.

In response to this letter, provide:

Identity, assay and impurity test results from testing retains for all lots of talc containing drug components used in the manufacture of your drug products. Alternatively, if a retain of a component lot is unavailable, perform retain sample testing of all implicated finished drug product batches for asbestos. Provide this information within 30 calendar days of the date of this letter.

A description of how you will test each component lot for conformity with all appropriate written specifications for identity, strength, quality, and purity. If you intend to accept any results from your supplier’s COA instead of testing each component lot for strength, quality, and purity, specify how you will establish the reliability of your supplier’s results through initial validation as well as periodic re-validation. In addition, include a commitment to always conduct at least one specific identity test for each incoming component lot.

A full risk assessment for drug products that are within expiry which contain any ingredient at risk for asbestos contamination. Take prompt and appropriate actions to determine the safety of all lots of the component(s) and any related drug product that could contain asbestos. Appropriate actions could include customer notifications and drug product recalls for any contaminated lots.

The chemical quality control specifications you use to evaluate each incoming lot of drug component to determine acceptability for use in manufacturing.

A summary of results obtained from testing all components to evaluate the reliability of the COA from each component manufacturer. Include your standard operating procedure that describes this COA validation program.

In response to our request for records you indicated that you are in the process of reformulating to remove talc as an ingredient and replace with corn starch. In response to this letter provide an update on your talc.

Talc is a USP article, whose specification can be found in the current USP talc monograph. As mentioned above, the specific test for asbestos is included in the talc monograph. Be advised that drugs including components, such as talc, that are recognized in the USP are generally required to meet the current applicable USP monograph under section 501(b) of the FD&C Act. FDA reviewed your specifications for talc components and they are incomplete when compared to the current USP specification. We note that the USP has recently revised its monograph for talc which includes updated technical requirements for asbestos testing in talc and is currently scheduled to be official in (b)(4).

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 are responsible for the quality of your drugs regardless of agreements in place with your contract facilities. 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.

The violations cited in this letter are not intended to be an all-inclusive list of violations that exist. 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 violation 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 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 Umendra Life Sciences Private Limited, New Survey No. 211, Village Account No. 170 Old, Block / Survey No. 158, Bavla, Taluka Mauje, Amipura, Ahmedabad, Gujarat 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. If you cannot complete corrective actions within 15 working days, state your reasons for delay and your schedule for completion. 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.

Send your electronic reply to CDER-OC-OMQ-Communications@fda.hhs.gov. Identify your response with FEI 3035187076 and ATTN: Nancy Espinal.