2026-06-24 FDA Warning Letter: Wizcure Pharmaa Private Limited Cited for CGMP/Finished Pharmaceuticals/Adulterated
Letter issued · posted to fda.gov .
Subject as published: CGMP/Finished Pharmaceuticals/Adulterated
TL;DR
The short version: FDA Center for Drug Evaluation and Research issued Warning Letter 320-26-97 to Wizcure Pharmaa Private Limited on June 24, 2026, following a December 3-10, 2025 inspection of its finished pharmaceutical manufacturing facility in Bhiwadi, Rajasthan, India, citing systematic Current Good Manufacturing Practice violations including falsified microbiological testing data, replacement of contaminated microbial plates with clean ones, pre-filled laboratory forms with test results, failure to collect required environmental and personnel monitoring samples, and unreliable microbial counts that compromised sterility assurance for aseptic processing. The FDA determined the facility's drug products are adulterated due to inadequate data integrity practices, suspended manufacturing, and requested comprehensive independent assessments of laboratory and documentation systems with detailed corrective and preventive action plans addressing organizational causes of the breaches.
Argus analysis
# FDA Warning Letter Analysis: Wizcure Pharmaa Private Limited
**Company and Violations**
Wizcure Pharmaa Private Limited, a drug manufacturer located in Bhiwadi, Rajasthan, India, received a Warning Letter from the FDA's Center for Drug Evaluation and Research (CDER) on June 24, 2026, following an inspection conducted December 3–10, 2025. The FDA found the facility produced adulterated over-the-counter sterile drugs due to significant Current Good Manufacturing Practice (CGMP) violations. The facility manufactures finished pharmaceutical products in aseptic conditions, and the inspection revealed systematic failures in laboratory data integrity and environmental controls critical to preventing contamination.
**Regulatory Citations**
The warning letter cites 21 CFR 211.194(a), which requires complete laboratory records with original data from all necessary tests ensuring compliance with specifications. It also references 21 CFR 211.42(c)(10), governing aseptic processing area design and separation. These regulations address two fundamental CGMP requirements: accurate documentation of quality control testing, and proper facility design to prevent contamination. The violations observed—including discarded microbial plates replaced with new ones, pre-filled laboratory forms with false results, and lack of physical barriers between ISO 5 and ISO 7 processing zones—directly compromise product sterility assurance.
**Timeline and Industry Watchpoints**
The company responded December 30, 2025, suspending manufacturing and engaging third-party consultants, though the FDA deemed the response inadequate. The letter demands comprehensive independent assessments of laboratory practices, documentation systems, and the aseptic processing line, with detailed remediation plans. Compliance officers monitoring this firm should track whether Wizcure submits credible corrective action plans addressing root causes, evidence of quality unit resource augmentation, and microbial sampling reforms. The absence of adequate response may trigger product seizure or import detention actions affecting supply chains dependent on this manufacturer.
Severity context
Critical severity. Typically reserved for data integrity, sterile-product CGMP, or repeat violations — matters that historically precede injunctions, consent decrees, or import alerts.
Regulatory background
CGMP citations typically reference 21 CFR Part 211 (drugs) or 21 CFR Part 600 (biologics). Common subjects include identity testing of incoming components (211.84), validated cleaning procedures (211.67), and stability program design (211.166).
What peer compliance teams typically do next
Most compliance officers at peer companies use a Warning Letter against a named entity as a checklist for their own CAPA program. Common steps: pull the verbatim FDA letter; map each cited 21 CFR section against the team’s SOP library; confirm CAPA coverage; brief the QMR (Quality Management Review) on whether the cited subject matter is in scope for the next internal audit. The 15-business-day response window applies to the cited entity, not to peers — but a documented internal review against the cited subjects is what regulators expect to see if a peer is later inspected on the same topic.
Excerpt from the FDA Warning Letter (public domain, 17 USC §105)
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, includin…
Excerpt only. The full verbatim Warning Letter is the source of truth — always read the original before regulatory decisions.
The verbatim FDA Warning Letter is the source of truth. Always read the original before acting on any analysis or summary on this page.
Read the full letter on fda.gov ↗Frequently asked questions
- When did FDA issue the warning letter to Wizcure Pharmaa Private Limited?
- FDA issued the letter (MARCS-CMS 726378) on 2026-06-24 and posted it publicly on fda.gov on 2026-06-30.
- Is the FDA warning letter to Wizcure Pharmaa Private Limited publicly available?
- Yes. The full verbatim letter is published at fda.gov. Argus HQ links directly to the source: https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/wizcure-pharmaa-private-limited-726378-06242026.
- What does a "critical" severity rating mean for this letter?
- Critical severity. Typically reserved for data integrity, sterile-product CGMP, or repeat violations — matters that historically precede injunctions, consent decrees, or import alerts.
- What is the regulatory background for a CGMP — Current Good Manufacturing Practice warning letter?
- CGMP citations typically reference 21 CFR Part 211 (drugs) or 21 CFR Part 600 (biologics). Common subjects include identity testing of incoming components (211.84), validated cleaning procedures (211.67), and stability program design (211.166).
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methodology
The analysis above is produced by Anthropic Claude Haiku 4.5 against the verbatim FDA Warning Letter excerpt and is brand-voice lint-checked before publish. The TL;DR is the same summary that ships in the customer email digest. Severity is auto-classified by Argus from the subject string and letter body using rules documented in lib/ingestion/fda-warning-letters.ts.
Argus HQ is informational only. Summaries and analyses are AI-generated and may contain errors, misclassifications, or omissions. Verify against the FDA source URL above. Argus HQ is not a law firm, accounting firm, or regulatory agency, and provides no legal, accounting, financial, medical, or regulatory advice.
Compiled by Argus HQ Research from FDA primary sources · Reviewed by Andy Gaber, Founder
Cite this record
Reusing this data in reporting or research? Here’s a ready-made citation.
Argus HQ Research (2026). 2026-06-24 FDA Warning Letter: Wizcure Pharmaa Private Limited Cited for CGMP/Finished Pharmaceuticals/Adulterated. Digital Empire LLC. Retrieved from https://argushq.ai/fda/warning-letter/fda-wl-wizcure-pharmaa-private-limited-2026-06-24-cgmp
"2026-06-24 FDA Warning Letter: Wizcure Pharmaa Private Limited Cited for CGMP/Finished Pharmaceuticals/Adulterated." Argus HQ Research, Digital Empire LLC, 2026, argushq.ai/fda/warning-letter/fda-wl-wizcure-pharmaa-private-limited-2026-06-24-cgmp.
Argus HQ Research. "2026-06-24 FDA Warning Letter: Wizcure Pharmaa Private Limited Cited for CGMP/Finished Pharmaceuticals/Adulterated." Digital Empire LLC. Accessed July 13, 2026. https://argushq.ai/fda/warning-letter/fda-wl-wizcure-pharmaa-private-limited-2026-06-24-cgmp.
@misc{argushq_argushq_ai_fda_warning_letter_fda_wl_wizcure_pharmaa_private_limited_2026_06_24_cgmp_2026,
title = {2026-06-24 FDA Warning Letter: Wizcure Pharmaa Private Limited Cited for CGMP/Finished Pharmaceuticals/Adulterated},
author = {{Argus HQ Research}},
year = {2026},
publisher = {Digital Empire LLC},
url = {https://argushq.ai/fda/warning-letter/fda-wl-wizcure-pharmaa-private-limited-2026-06-24-cgmp},
note = {Accessed: July 13, 2026}
}