# FDA 483 - Intas Pharmaceuticals Ltd. - January 24, 2024

Source: https://www.globalkeysolutions.net/records/483/intas-pharmaceuticals-ltd/d70a81b4-0d15-46af-af29-56ed1c0dc3c1

> FDA 483 for Intas Pharmaceuticals Ltd. on January 24, 2024. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Intas Pharmaceuticals Ltd.
- Inspection Date: 2024-01-24
- Product Type: drugs
- Office Name: Office of Biological Products Operations - Division I
- Summary: An FDA inspection of Intas Pharmaceuticals Limited in Dehradun, India, revealed significant deficiencies in quality control, aseptic processing, and laboratory practices. The firm failed to conduct adequate investigations into out-of-specification results and market complaints, maintain proper environmental monitoring, and ensure the integrity of its sterile manufacturing processes. These findings indicate a lack of robust quality systems and adherence to established procedures.

## Related Documents

- [483 - 2023-01-20](https://www.globalkeysolutions.net/records/483/intas-pharmaceuticals-ltd/21016793-b807-41b4-97f1-d21510336034)
- [483 - 2025-09-17](https://www.globalkeysolutions.net/records/483/intas-pharmaceuticals-ltd/80904191-e341-4855-ab11-f5e543dc08e3)

## Related Officers

- [Consumer Safety Officer](https://www.globalkeysolutions.net/people/jeffrey-p-raimondi/7576ca4e-d9e8-4015-9ae6-9498e76058d3)
- [Investigator](https://www.globalkeysolutions.net/people/patty-p-kaewussdangkul/1f0961fc-216e-4580-830a-56a76c0e7cea)
- [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-biological-products-operations-division-i/49c53dac-7724-4c8c-8708-4f5779ea69c1