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

Source: https://www.keypedia.com/records/483/intas-pharmaceuticals-limited/aaef987c-6382-4641-8d0e-9fc48ace87ba

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

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## Details

- Record Type: 483
- Company Name: Intas Pharmaceuticals Limited
- Inspection Date: 2022-12-02
- Office Name: Office of Pharmaceutical Quality Operations
- Summary: The FDA Form 483 documents multiple violations at an unnamed facility, indicating significant deficiencies in laboratory practices, quality control, and manufacturing processes.

**Laboratory and Quality Control Issues:**
*   **Incomplete Data:** Laboratory records lack complete data from tests necessary for specification compliance.
*   **Inaccurate Environmental Monitoring:** Environmental monitoring samples were inaccurately counted, with reported results less than actual colony counts. A practice of counting merged colonies as one led to undercounting.
*   **Missing Raw Data:** Printouts, used as raw data, could not be provided for review during reconciliation of analysis performed on January 13, 2021, for instrument SC1111.
*   **Unfollowed Procedures:** Established test procedures and laboratory control mechanisms are not consistently followed.
*   **Uncontrolled Data Integration:** No procedure exists for manually entered integration events in chromatography data, and reviewers only examine final chromatograms, not original ones, to justify manual changes.
*   **Quality Unit Failure:** The Quality Control Unit's responsibilities and procedures are not fully followed, demonstrating a "cascade of failure" in managing GMP documents critical for drug product safety and effectiveness.
*   **Unvalidated Test Methods:** The accuracy, sensitivity, specificity, and reproducibility of test methods have not been established.
*   **Inadequate Computer Controls:** Controls over computer systems are insufficient to ensure only authorized personnel institute changes to master production and control records.

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## Related Documents

- [WARNING_LETTER - 2025-09-17](https://www.keypedia.com/records/warning_letter/intas-pharmaceuticals-limited/5823afb5-cd04-4920-9a5a-ce851b44651c)
- [483 - 2018-06-08](https://www.keypedia.com/records/483/intas-pharmaceuticals-limited/6c433282-acc9-4639-89b9-e51ca154262e)
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## 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/0db00702-d7f6-4a8b-87d1-1b32ac236cc8

Office: https://www.keypedia.com/offices/office-of-pharmaceutical-quality-operations/6b0153a9-c1d1-46a5-8b10-836d2ae44ffe