# FDA 483 - Lupin Limited - November 23, 2022

Source: https://www.globalkeysolutions.net/records/483/lupin-limited/a8b2c8e0-ce26-40d8-ba9d-12baf6bad6fc

> FDA 483 for Lupin Limited on November 23, 2022. Product: N/A. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Lupin Limited
- Inspection Date: 2022-11-23
- Office Name: Division of Pharmaceutical Quality Operations IV
- Summary: This FDA Form 483 documents multiple observations from an inspection, indicating significant deficiencies in the facility's quality system and manufacturing operations.

Key violations include:
*   **Inadequate investigations:** Failure to thoroughly review unexplained discrepancies, batch failures, or out-of-specification results, including root cause determination for API/intermediate failures.
*   **Data integrity and computer system controls:** Lack of appropriate controls over computer systems to ensure changes to master production/control records are by authorized personnel, and insufficient controls to prevent unauthorized access or data changes.
*   **Documentation and recordkeeping:** Failure to maintain production, control, distribution, component, and labeling records for at least one year past expiration. Written procedures for annual batch record evaluations are not established.
*   **Quality Control Unit deficiencies:** Responsibilities and procedures for the quality control unit are not in writing and fully followed. The deviation handling SOP is silent on the content of trend evaluations.
*   **Equipment design and maintenance:** Equipment lacks appropriate design for intended use, cleaning, and maintenance. Routine calibration of automatic/mechanical equipment is not performed according to a written program.
*   **Process control and validation:** Critical process parameters for APIs/intermediates are not continuously monitored. Validation batch records for API Process Performance Qualification lack measurable values for raw material loading, with no documentation of quantity.
*   **Engineering practices:** Concerns exist regarding current engineering practices, despite training. The SOP for drawing/layout approval is silent

## Related Documents

- [483 - 2018-12-04](https://www.globalkeysolutions.net/records/483/lupin-limited/7563e21c-3de3-472c-b7c2-896029346d00)
- [483 - 2018-12-04](https://www.globalkeysolutions.net/records/483/lupin-limited/4a7b4f58-35ab-46da-bb80-3ddb7dbc5325)
- [483 - 2022-11-23](https://www.globalkeysolutions.net/records/483/lupin-limited/9526924e-9742-43cf-b424-a50ea10b302e)

## Related Officers

- [Consumer Safety Officer](https://www.globalkeysolutions.net/people/rajiv-r-srivastava/05b42bfd-0cf4-42ce-89e1-b81bf36eaa17)
- [Thomas J. Arista](https://www.globalkeysolutions.net/people/thomas-j-arista/37905892-3285-4f3f-b4b5-f963df1e59d3)

Company: https://www.globalkeysolutions.net/companies/lupin-limited/122cdc90-be58-47a6-8127-004b3a6a04c3

Office: https://www.globalkeysolutions.net/offices/division-of-pharmaceutical-quality-operations-iv/a2d2ff91-dc0f-433e-b91f-ca90ff8998b6