# FDA 483 - Intas Pharmaceuticals Limited - December 02, 2022

Source: https://www.keypedia.com/records/483/intas-pharmaceuticals-limited/51f72db3-f323-4bb3-9458-0baa02a1227d

> FDA 483 for Intas Pharmaceuticals Limited on December 02, 2022. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Intas Pharmaceuticals Limited
- Inspection Date: 2022-12-02
- Product Type: drugs
- Office Name: Office of Biological Products Operations - Division I
- Summary: Intas Pharmaceuticals Limited received a Form 483 citing significant data integrity and quality control failures. Observations included destruction of GMP documents, manipulation of chromatography data to avoid OOS results, inadequate environmental monitoring in aseptic areas, and insufficient process and analytical method validation. These issues indicate a systemic lack of oversight and control over critical manufacturing and testing processes for drug products.

## Related Documents

- [483 - 2019-05-28](https://www.keypedia.com/records/483/intas-pharmaceuticals-limited/ce617d78-cad5-4a6b-9b44-9d98421912d8)
- [483 - 2020-02-28](https://www.keypedia.com/records/483/intas-pharmaceuticals-limited/4840cbe4-0699-45d1-b557-35037fad9e93)
- [WARNING_LETTER - 2022-12-02](https://www.keypedia.com/records/warning_letter/intas-pharmaceuticals-limited/69e72c80-0677-41df-92b7-50c9a9d7402e)
- [WARNING_LETTER - 2023-05-12](https://www.keypedia.com/records/warning_letter/intas-pharmaceuticals-limited/9e0758c3-e43d-4af6-8f19-a85862cedff3)

## Related Officers

- [Pratik S. Upadhyay](https://www.keypedia.com/people/pratik-s-upadhyay/22ff2e0b-17d4-4c91-a3f0-c7e30b7a115b)
- [Quality System Specialist](https://www.keypedia.com/people/jose-e-melendez/75bd6083-14a4-4bd2-a0e5-9946d4dd37e1)
- [Research Specialist II](https://www.keypedia.com/people/justin-a-boyd/796c9c9d-02db-486c-bdca-cc259066a0e2)

Company: https://www.keypedia.com/companies/intas-pharmaceuticals-limited/cfedbb2f-5587-42dc-985b-044083dd01e5

Office: https://www.keypedia.com/offices/office-of-biological-products-operations-division-i/49c53dac-7724-4c8c-8708-4f5779ea69c1