June 24, 2026 FDA Warning Letter: Wizcure Pharmaa Private Limited Cited for CGMP/Finished Pharmaceuticals/Adulterated

FDA Warning Letter — Violations FDA cited at Wizcure Pharmaa Private Limited

WARNING LETTER Wizcure Pharmaa Private Limited MARCS-CMS 726378 — June 24, 2026 More Warning Letters Warning Letters About Warning and Close-Out Letters Delivery Method: Via Electronic Mail - Return Receipt Requested Reference #: 320-26-97 Product: Drugs Over-the-Counter Drugs Recipient: Recipient Name Mr. Ashish Arun Dange Recipient Title Managing Director Wizcure Pharmaa Private Limited PGN 02-1403, Emaar Palm Gardens Sector 83 Gurgaon 122004 Haryana India Issuing Office: Center for Drug Evaluation and Research (CDER) United States Warning Letter 320-26-97 June 24, 2026 Dear Mr. Dange: The United States Food and Drug Administration (FDA) inspected your drug manufacturing facility, Wizcure Pharmaa Private Limited, 3030304532, located at H-881, Phase III, RIICO Industrial Area Bhiwadi, Rajasthan, India, from December 3 to 10, 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 December 30, 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 ensure that laboratory records included complete data derived from all tests necessary to ensure compliance with established specifications and standards (21 CFR 211.194(a)). You lacked complete and original laboratory data demonstrating that the required testing was performed. For example, our investigator observed (b)(4) personnel monitoring microbial plates in your laboratory incubator with visible microbial growth. The next day, our investigator observed microbial plates with the same identification information with no growth. Both management and a microbiologist confirmed that the original microbial plates were discarded and replaced with new plates. This false data misrepresented the ISO 5 environmental conditions of your aseptic processing line. Additionally, our inspection found that you frequently failed to collect environmental monitoring, personnel monitoring, and (b)(4) samples, as required by your procedure. For example, personnel monitoring contact plates were not collected on November 29, 2025, during the manufacturing of (b)(4) solution USP (b)(4) batches (b)(4) and (b)(4) . We also identified critical discrepancies in your sample test results. We found that you failed to reliably incubate samples and record accurate microbial counts. For example, our inspection repeatedly found unreliable and incorrect microbiology data, including, but not limited to, environmental monitoring samples. In addition, we identified other significant discrepancies in sample description, identification, and reconcilability. Our investigators also found laboratory forms were pre-filled with microbial testing information (e.g., sterility and (b)(4) testing results), further demonstrating untrustworthy documentation. Significantly, when your firm actually obtained environmental monitoring samples and we closely tracked the plates during our inspection, we noted several instances in which microbial contamination was present in your ISO 5 processing environment. Our inspectional findings indicate serious recurring data integrity breaches in your laboratory relating to critical microbiological tests and monitoring. Microbial monitoring and testing are essential quality control steps that are integral in preventing distribution of unsafe products. Such programs provide critical information on the state of control of the aseptic processing