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

Source: https://www.keypedia.com/records/483/intas-pharmaceuticals-ltd/d7eff99e-98c8-4f11-a560-2905abeaffc1

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

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## Details

- Record Type: 483
- Company Name: Intas Pharmaceuticals Ltd.
- Inspection Date: 2025-09-17
- Product Type: drugs
- Office Name: Office of Inspections and Investigations
- Summary: Between September 8 and September 17, 2025, the U.S. Food and Drug Administration (FDA) conducted an inspection of the Intas Pharmaceuticals Limited facility located in Dehradun, India. The resulting report outlines several significant violations regarding the firm"s compliance with manufacturing and quality standards. A major concern involves the company"s failure to investigate failed test results. Specifically, the FDA found that the shelf-life assigned to certain tablet products was not supported by stability data. Despite repeated adjustments to these expiration dates, the company recorded over 20 failed results and was forced to recall a batch, yet they provided an inadequate assessment of the impact on other products distributed to the U.S. market. Furthermore, the inspection uncovered serious data integrity issues. Quality assurance staff bypassed official quality systems by requesting a software vendor to manually alter signed electronic manufacturing records. These unauthorized changes included modifying electronic signatures, operator identities, and production weights without leaving a record in the system"s digital audit trail. The FDA also noted that employees used shared email accounts and passwords to conduct official business and deleted records of these instructions. Lastly, the firm was unable to produce complete manufacturing records for certain batches, claiming they were lost without conducting a proper investigation. These findings indicate a failure to follow established quality control procedures. Intas Pharmaceuticals is required to provide the FDA with a formal response detailing the corrective actions they will implement to resolve these deficiencies.

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- [483 - 2025-09-17](https://www.keypedia.com/records/483/intas-pharmaceuticals-ltd/80904191-e341-4855-ab11-f5e543dc08e3)

## Related Officers

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

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

Office: https://www.keypedia.com/offices/office-of-inspections-and-investigations/7dd0b904-a3df-46bc-a7b2-70ddb6f809c8