# FDA 483 - Intas Pharmaceuticals Ltd. - Unknown Date

Source: https://www.keypedia.com/records/483/intas-pharmaceuticals-ltd/23b75ae0-92f2-496d-87b8-abd03dd683df

> FDA 483 for Intas Pharmaceuticals Ltd. on Unknown Date. Product: biologics. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Intas Pharmaceuticals Ltd.
- Product Type: biologics
- Office Name: Division of Clinical Evidence and Analysis 1 (Clinical Policy and Quality)
- Summary: Intas Pharmaceuticals Ltd. received a Form 483 citing significant deficiencies across multiple areas, including data integrity issues in laboratory records and computer systems, inadequate control over records, insufficient investigation procedures, and failures in aseptic processing controls. The observations highlight a systemic lack of adherence to established procedures and proper quality oversight, impacting product quality and data reliability.

## Related Documents

- [483 - 2017-05-10](https://www.keypedia.com/records/483/intas-pharmaceuticals-ltd/60d62c4f-e4ca-403c-bcdf-6c06c5f8d7fd)
- [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)
- [483 - 2025-02-14](https://www.keypedia.com/records/483/intas-pharmaceuticals-ltd/781f056c-1c11-4569-a13e-48264c8a881f)

## Related Officers

- [Bijoy Panicker](https://www.keypedia.com/people/bijoy-panicker/1c6ec57f-e02e-49b8-8b59-1853f3d2947a)
- [ Assistant Country Director (USFDA India Office Drug Program)](https://www.keypedia.com/people/daniel-j-roberts/1e1836ac-8bca-4236-a267-33ee0456440c)
- [Patric C. Klotzbuecher](https://www.keypedia.com/people/patric-c-klotzbuecher/cbb2e6b5-b001-457e-9073-33535f02926e)

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

Office: https://www.keypedia.com/offices/division-of-clinical-evidence-and-analysis-1-clinical-policy-and-quality/5f95da17-30bb-423f-b892-5ea041823fbd