# FDA 483 - Intas Pharmaceuticals Ltd. - February 14, 2025

Source: https://www.keypedia.com/records/483/intas-pharmaceuticals-ltd/781f056c-1c11-4569-a13e-48264c8a881f

> FDA 483 for Intas Pharmaceuticals Ltd. on February 14, 2025. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Intas Pharmaceuticals Ltd.
- Inspection Date: 2025-02-14
- Product Type: drugs
- Office Name: Office of Inspections and Investigations
- Summary: Intas Pharmaceuticals Limited received an FDA Form 483 citing significant deficiencies in its aseptic manufacturing processes, quality unit oversight, and facility maintenance. Repeat observations from previous inspections highlight persistent issues with microbial contamination prevention, inadequate environmental monitoring, and a lack of adherence to established procedures, indicating a systemic failure to ensure drug product quality and purity.

## Related Documents

- [483 - 2017-05-10](https://www.keypedia.com/records/483/intas-pharmaceuticals-ltd/60d62c4f-e4ca-403c-bcdf-6c06c5f8d7fd)
- [483 - Unknown Date](https://www.keypedia.com/records/483/intas-pharmaceuticals-ltd/23b75ae0-92f2-496d-87b8-abd03dd683df)
- [483 - 2022-08-09](https://www.keypedia.com/records/483/intas-pharmaceuticals-ltd/46d0eee8-16f1-4b8d-b257-0599a7409190)
- [483 - 2023-12-07](https://www.keypedia.com/records/483/intas-pharmaceuticals-ltd/83848914-69b1-4d19-b2fb-ad19cbd9e73f)

## Related Officers

- [Deepa Singh, PharmD, MS-RAQA](https://www.keypedia.com/people/deepa-singh-pharmd-ms-raqa/13e0efc4-9823-4c91-a07e-f9fe3a3a6f98)
- [Hamet Touré, PharmD MPH](https://www.keypedia.com/people/hamet-toure-pharmd-mph/611bd66b-e975-4be5-9ac5-7a2ee17bfd91)
- [investigator](https://www.keypedia.com/people/amy-hsu/78472f98-f37f-4534-bb3b-43f58a18266e)
- [other](https://www.keypedia.com/people/hamet-m-toure/9f3726f3-b118-4247-9793-738557aa1ee8)
- [Doan N. Singh](https://www.keypedia.com/people/doan-n-singh/e52cfbca-5710-4765-8c5e-d534946b648d)

Company: https://www.keypedia.com/companies/intas-pharmaceuticals-ltd/b19b63c2-446c-413c-9c30-1617f981d92a

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