# FDA 483 - Lupin Manufacturing Solutions Limited - January 17, 2020

Source: https://www.globalkeysolutions.net/records/483/lupin-manufacturing-solutions-limited/a9b30d56-7ebd-41de-8ce5-2a10a5805359

> FDA 483 for Lupin Manufacturing Solutions Limited on January 17, 2020. Product: N/A. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Lupin Manufacturing Solutions Limited
- Inspection Date: 2020-01-17
- Office Name: Office of Pharmaceutical Quality Operations
- Summary: This FDA Form 483 document details observations from an inspection, highlighting deficiencies in critical process parameter control, discrepancy investigations, secondary reference standard management, and raw material sampling.

**Facility and Operation Details:** The document refers to the production of intermediates and Active Pharmaceutical Ingredients (API), including exhibit batches and process performance qualification (PPQ) studies.

**Violations and Observations:**

*   **Process Validation Deficiencies:**
    *   Failure to identify critical process parameters (CPPs) during PPQ studies. For example, "Quantity of" was identified as a CPP, while other parameters crucial for chemical reactions were deemed non-critical in PPQ protocols/reports (PVP/MPP1/065/00, PVR/MPP1/063/00, PVR/MPP1/068/00).
    *   Failure to perform hold time studies during critical processes and production steps. Hold time studies were only conducted after all chemical reactions were complete.
*   **Discrepancy Investigation Failure:** The firm failed to thoroughly review unexplained discrepancies, even for distributed batches. Specifically, during exhibit batch production and PPQ studies, discrepancies were not investigated in a timely manner. Instead, a change control was initiated to revise product limits for API (e.g., exhibit batch results for batch #, batch #, and batch # showed varying results).
*   **Secondary Reference Standard Deficiencies:**

## Related Documents

- [483 - 2020-01-17](https://www.globalkeysolutions.net/records/483/lupin-manufacturing-solutions-limited/23c400c0-6de8-4bfd-a3f8-971f0c77cf7b)

## Related Officers

- [Compliance Officer](https://www.globalkeysolutions.net/people/yasamin-ameri/73021772-c960-4c65-aa30-cb490866ee58)

Company: https://www.globalkeysolutions.net/companies/lupin-manufacturing-solutions-limited/aa17e052-450b-4bc5-b441-515d96f18b2d

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