# FDA 483 - Enzene Biosciences Limited - February 13, 2026

Source: https://www.globalkeysolutions.net/records/483/enzene-biosciences-limited/b2dd84ba-77b1-40d0-b78d-f88b8ce6572b

> FDA 483 for Enzene Biosciences Limited on February 13, 2026. Product: drugs. Access full analysis and detailed observations.

---

## Details

- Record Type: 483
- Company Name: Enzene Biosciences Limited
- Inspection Date: 2026-02-13
- Product Type: drugs
- Office Name: Division of Clinical Evidence and Analysis 1 (Clinical Policy and Quality)
- Summary: Enzene Biosciences Limited, a drug substance and drug product manufacturer in Pune, India, received a Form 483 for significant deficiencies observed during an FDA inspection. The findings highlight critical issues in aseptic processing, quality control procedures, adherence to written protocols, and overall quality oversight. These observations collectively indicate a high risk to product quality and sterility assurance.

## Related Officers

- [Rapti Madurawe, Ph.D. Division Director](https://www.globalkeysolutions.net/people/rapti-madurawe-phd-division-director/1301553b-008c-48c8-b0ec-7029b4545ae7)
- [Qiao Bobo, Ph.D. Division Director](https://www.globalkeysolutions.net/people/qiao-bobo-phd-division-director/6ed34b60-6ce6-4dcc-adf2-07eced1f04d9)
- [Sazarachcha Duwimkulumbur, M.D., Ph.D., Lead Interdisciplinary Scientist](https://www.globalkeysolutions.net/people/sazarachcha-duwimkulumbur-md-phd-lead-interdisciplinary-scientist/be83910c-dbfb-4250-943d-73aa5d80b3cf)

Company: https://www.globalkeysolutions.net/companies/enzene-biosciences-limited/97535332-2de5-4276-a45e-400e486ce701

Office: https://www.globalkeysolutions.net/offices/division-of-clinical-evidence-and-analysis-1-clinical-policy-and-quality/5f95da17-30bb-423f-b892-5ea041823fbd