FDA Warning Letter to Umendra Life Sciences Private Limited (June 2, 2026) — CGMP/OTC Finished Pharmaceuticals/Adulterated

FDA Warning Letter — Violations FDA cited at Umendra Life Sciences Private Limited

WARNING LETTER Umendra Life Sciences Private Limited MARCS-CMS 721752 — June 02, 2026 More Warning Letters Warning Letters About Warning and Close-Out Letters Delivery Method: VIA UPS Reference #: 320-26-91 Product: Drugs Over-the-Counter Drugs Recipient: Recipient Name Mr. Ankur Sharma Sr. Recipient Title General Manager – Quality Umendra Life Sciences Private Limited New Survey No. 211, Village Account No. 170 Old Block Survey No. 158, Bavla, Taulka Mauje Ahmedabad 382220 Gujarat India Issuing Office: Center for Drug Evaluation and Research (CDER) United States Warning Letter 320-26-91 June 2, 2026 Dear Mr. Sharma: 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