# FDA 483 - WIZCURE PHARMAA PRIVATE LIMITED - December 03, 2025

Source: https://www.keypedia.com/records/483/wizcure-pharmaa-private-limited/d3939b4c-bc2e-4b85-be5e-b48c6e68d549

> FDA 483 for WIZCURE PHARMAA PRIVATE LIMITED on December 03, 2025. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: WIZCURE PHARMAA PRIVATE LIMITED
- Inspection Date: 2025-12-03
- Product Type: drugs
- Office Name: Office of Partnerships
- Summary: Wizcure Pharmaa Private Limited, a sterile drug manufacturer in Bhiwadi, India, received a Form 483 with severe observations. The inspection revealed significant data integrity issues, including falsified microbiology records and pre-filled test results, alongside widespread deficiencies in aseptic processing, environmental monitoring, and quality control practices. These findings indicate a critical lack of control over sterile drug manufacturing processes and data reliability.

## Related Documents

- [483 - 2025-12-10](https://www.keypedia.com/records/483/wizcure-pharmaa-private-limited/6ed273f4-c9a4-4e75-8940-701f7651bf3e)
- [WARNING_LETTER - 2025-12-10](https://www.keypedia.com/records/warning_letter/wizcure-pharmaa-private-limited/b922fc42-526d-48ff-bc57-4289c1e8cb6c)

## Related Officers

- [Consumer Safety Officer/ Federal Investigator](https://www.keypedia.com/people/lisa-l-flores/465a6807-55d7-4c3f-a415-c21ac4517bc9)
- [Investigator?](https://www.keypedia.com/people/robert-j-ham/9146e819-4fce-420c-a722-cbe14e3c6afb)

Company: https://www.keypedia.com/companies/wizcure-pharmaa-private-limited/7ddaac90-981c-4180-9174-423cfa950bc5

Office: https://www.keypedia.com/offices/office-of-partnerships/83acc701-fc5a-4876-bb34-7499e31541d3