# FDA 483 - Intas Pharmaceuticals Ltd. - September 17, 2025

Source: https://www.globalkeysolutions.net/records/483/intas-pharmaceuticals-ltd/80904191-e341-4855-ab11-f5e543dc08e3

> FDA 483 for Intas Pharmaceuticals Ltd. on September 17, 2025. Product: drugs. Access full analysis and detailed observations.

---

## Details

- Record Type: 483
- Company Name: Intas Pharmaceuticals Ltd.
- Inspection Date: 2025-09-17
- Product Type: drugs
- Office Name: Office of Pharmaceutical Quality Operations
- Summary: Intas Pharmaceuticals Limited in Dehradun, India, was inspected from September 8-17, 2025, and received a Form 483 with three observations. The inspection revealed significant issues including inadequate review of unexplained discrepancies, unsupported drug product shelf-life, and numerous out-of-specification results. Furthermore, the firm was cited for unauthorized modifications to electronic batch records without proper audit trails, and for incomplete batch production and control records.

## Related Documents

- [483 - 2023-01-20](https://www.globalkeysolutions.net/records/483/intas-pharmaceuticals-ltd/21016793-b807-41b4-97f1-d21510336034)
- [483 - 2024-01-24](https://www.globalkeysolutions.net/records/483/intas-pharmaceuticals-ltd/d70a81b4-0d15-46af-af29-56ed1c0dc3c1)

## Related Officers

- [Saleem A. Akhtar](https://www.globalkeysolutions.net/people/saleem-a-akhtar/1ea49212-bea5-4d43-bd0a-cdede4d3b1cf)
- [Consumer Safety Officer - Dedicated Foreign Drug Cadre](https://www.globalkeysolutions.net/people/tamil-arasu/94efc491-7d9f-4221-a1ee-69a925acb1c3)

Company: https://www.globalkeysolutions.net/companies/intas-pharmaceuticals-ltd/80196b90-d49a-45f1-97f4-17ffd8678140

Office: https://www.globalkeysolutions.net/offices/office-of-pharmaceutical-quality-operations/6b0153a9-c1d1-46a5-8b10-836d2ae44ffe