# FDA 483 - Intas Pharmaceuticals Ltd. - January 20, 2023

Source: https://www.globalkeysolutions.net/records/483/intas-pharmaceuticals-ltd/21016793-b807-41b4-97f1-d21510336034

> FDA 483 for Intas Pharmaceuticals Ltd. on January 20, 2023. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Intas Pharmaceuticals Ltd.
- Inspection Date: 2023-01-20
- Product Type: drugs
- Office Name: Office of Biological Products Operations - Division I
- Summary: An FDA inspection of Intas Pharmaceuticals Ltd. in Dehradun, India, a finished drug product manufacturer, revealed significant deficiencies across multiple areas. The firm failed to establish and follow procedures for preventing microbiological contamination in sterile and non-sterile drug products, and lacked scientific evidence in out-of-specification investigations. Critical issues were also noted in process validation, equipment qualification, quality control unit oversight, and data integrity for computerized systems.

## Related Documents

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## Related Officers

- [Tereza J Navas](https://www.globalkeysolutions.net/people/tereza-j-navas/d2dd8ba8-863e-48de-831e-df047282045b)
- [Arsen Karapetyan](https://www.globalkeysolutions.net/people/arsen-karapetyan/4000d909-277b-4533-992f-4e3627c8ce40)

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