TL;DR
- Company: Wizcure Pharmaa Private Limited, a sterile OTC drug manufacturer in Bhiwadi, Rajasthan, India.
- Date: Warning Letter 320-26-97 issued June 24, 2026 (MARCS-CMS 726378).
- Classification: CGMP / Finished Pharmaceuticals / Adulterated (sterile OTC drug products).
- Key citations: Incomplete lab records tied to a microbial-plate swap (211.194(a)), no barrier between the ISO 5 aseptic line and the ISO 7 room (211.42(c)(10)), deficient process simulations (211.113(b)), and rusted equipment (211.67(a)).
- Consequence: FDA placed the firm on Import Alert 66-40 on December 23, 2025; the company committed to stop manufacturing and distribution and to a voluntary recall, but FDA found its response inadequate on all four citations.
| Company | Location | Letter # | Issued | Issuing Office | Inspection Dates | Classification |
|---|---|---|---|---|---|---|
| Wizcure Pharmaa Private Limited | H-881, Phase III, RIICO Industrial Area, Bhiwadi, Rajasthan, India | 320-26-97 (MARCS-CMS 726378) | June 24, 2026 | CDER | December 3–10, 2025 | CGMP / Finished Pharmaceuticals / Adulterated |
"Original plates were discarded and replaced with new plates." That is how management and a staff microbiologist explained it, after an inspector watched personnel monitor microbial plates sitting in an incubator with visible growth, only to find the next day that plates with the same identification numbers showed no growth at all. The admission sits inside the FDA Warning Letter 320-26-97, June 24, 2026, addressed to Managing Director Ashish Arun Dange.
Wizcure Pharmaa manufactures sterile OTC drug products at its Bhiwadi, Rajasthan facility. FDA inspected the plant December 3–10, 2025. Four CFR citations followed. Read in sequence, they trace one story: a quality system that could not be trusted to report what its own environment looked like, inside a room never built to keep that environment sterile.
What the inspector found, in order
First, the plate swap (21 CFR 211.194(a)). An investigator watches personnel monitor plates already showing microbial growth in the incubator. The next day, plates carrying identical IDs show nothing. Management and a microbiologist confirm the originals were thrown out and replaced. Not a paperwork lapse. A fabricated result standing in for a real one.
Then, missing samples and pre-filled forms. Wizcure frequently failed to collect environmental and personnel monitoring samples it was required to collect; FDA cites personnel monitoring contact plates not collected on November 29, 2025, during manufacturing of certain batches. Separately, investigators found laboratory forms pre-filled with microbial testing results before testing had even occurred. No sample means no data. A pre-filled result means no test at all.
Finally, contamination the firm's own system had missed. When FDA closely tracked plates during the inspection itself, rather than relying on the firm's reporting, it found microbial contamination present in the ISO 5 processing environment, the sterile core of the aseptic line. Contamination the firm's ordinary monitoring had not been catching, or had been erasing.
The room wasn't built to contain the problem
The second major citation, 21 CFR 211.42(c)(10), describes a facility-design failure that helps explain why contamination could reach the ISO 5 zone at all. FDA found no physical barrier separating the ISO 5 (Grade A) aseptic filling line from the surrounding ISO 7 (Grade B) room and its personnel. Equipment parts in direct contact with product, containers, and closures were not sterilized. No wall, no barrier system, nothing between the most sterile point in the process and the ordinary room air around it.
Two more citations round out the letter. Under 21 CFR 211.113(b), the firm's aseptic process simulations, the media fills meant to prove a line can run sterile, were not representative of actual manufacturing conditions; batch records lacked complete documentation of personnel and interventions; and the firm ran static smoke studies rather than dynamic ones. A static study shows how air behaves in an empty room. A dynamic one shows how it behaves during actual filling, with people and equipment moving. Only the second kind tells you anything about a real aseptic operation.
Under 21 CFR 211.67(a), FDA cited the physical state of the equipment: aseptic processing equipment and the HEPA filters and diffuser grids above the filling line were in what the letter calls a "poor state of repair," with rust observed directly on the equipment and filtration components. Rust sheds particulate, and rust on the filters meant to keep the air clean is a contamination source built into the ceiling.
Why FDA rejected the response
Wizcure responded on December 30, 2025. The firm suspended manufacturing and engaged a third-party consultant. FDA reviewed that response against all four citations and found it inadequate on every one: no evidence the quality unit had the resources or expertise to catch fabricated results going forward; no comprehensive evaluation of whether the aseptic facility was even suitable for sterile manufacturing; insufficient batch record detail to show the firm understood what a representative media fill requires; and, on equipment, no retrospective risk assessment of batches made on the rusted, unsuitable equipment.
A suspended line and a hired consultant are actions. FDA's four rejections say those actions didn't answer the actual question at each citation: not what will you do differently, but what happened to product already made.
FDA had already held a teleconference with the firm on December 18, 2025, recommending removal of affected batches from the U.S. market. Wizcure committed on December 30, 2025, to cease manufacturing and distribution and to a voluntary recall. FDA placed the firm's drugs on Import Alert 66-40 on December 23, 2025, before that commitment was made. The letter closes with FDA's standard language: failure to promptly and adequately address the violations may result in seizure, injunction, or other legal action, without further notice. FDA also pointed the firm to its guidance on Data Integrity and Compliance With Drug CGMP and recommended a CGMP consultant under 21 CFR 211.34.
What this means for other sterile manufacturers
Two things here travel beyond one Bhiwadi facility. First, a data-integrity finding rarely arrives alone. The fabricated plates and the missing barrier are the same failure seen from two angles: a quality system that could not see contamination, or chose not to report it, inside a room that made contamination more likely. Auditors should treat a data-integrity red flag as a reason to re-examine facility design, not a separate finding.
Second, "we stopped and hired a consultant" is not, by itself, adequate. FDA asked for something more specific at every citation: proof the quality unit can catch the next fabrication, a facility-suitability evaluation, complete batch records, and a retrospective look at product already made on defective equipment. Fixing the process forward without accounting for what already shipped invites the same four-for-four rejection Wizcure received.
FAQ
What products does the Wizcure Pharmaa warning letter cover?
Sterile OTC drug products manufactured at the firm's Bhiwadi, Rajasthan, India facility. The letter does not name specific products beyond describing them as sterile OTC drugs.
What was the microbial-plate incident FDA cited?
An FDA investigator observed personnel monitoring plates in an incubator showing visible microbial growth. The next day, plates with the same identification numbers showed no growth. Management and a staff microbiologist confirmed the originals had been discarded and replaced with new ones.
Is Wizcure Pharmaa currently allowed to ship product to the U.S.?
No. FDA placed the firm's drugs on Import Alert 66-40 on December 23, 2025, which authorizes detention without physical examination. The firm also committed on December 30, 2025, to cease manufacturing and distribution and to a voluntary recall.
Did FDA accept Wizcure's response to the inspection findings?
No. FDA reviewed the December 30, 2025 response against all four citations and found it inadequate on each one.
Source: FDA Warning Letter 320-26-97, June 24, 2026. Byline: The Argus Regulatory Analysis Team. Published 2026-07-07.
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