# FDA 483 - Lupin Limited - April 07, 2017

Source: https://www.keypedia.com/records/483/lupin-limited/5b03dcef-96a2-45dd-a350-c8c84d97189e

> FDA 483 for Lupin Limited on April 07, 2017. Product: N/A. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Lupin Limited
- Inspection Date: 2017-04-07
- Summary: The FDA Form 483 document details significant deficiencies in a pharmaceutical firm's quality control and manufacturing processes from January 2015 to March 2017.

**Key Violations and Observations:**

*   **Inadequate Out-of-Specification (OOS) Investigations:** The firm repeatedly failed to thoroughly review unexplained discrepancies and OOS results. Several initial OOS results were invalidated through re-testing without reaching assignable causes or implementing appropriate corrective and preventative actions (CAPAs).
    *   For example, OOS investigations for Tablets, mg (Batch ) and Tablets, USP mg (Batch ) attributed failures to evaporated sample solvent but lacked CAPAs to prevent recurrence.
    *   OOS for USP, Batch (API testing) was invalidated as an outlier without an assignable cause.
    *   Content Uniformity failures for Tablets, mg (Batches and ) were attributed to "improper rinsing of shaft" based on assumption, not scientific evaluation, and manufacturing processes were not reviewed.
    *   An Out-of-Trend (OOT) investigation for Tablets, mg (Batch ) concluded "improper of the sample" without reviewing the manufacturing process despite increasing variability.
    *   API Particle Size OOS for USP, Batch was invalidated without adequate investigation, citing "probably due to or sampling handling" without conclusive evidence.

*   **Deficient Laboratory Analyst Training:** Training for laboratory analysts regarding investigations purportedly caused by laboratory

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## Related Officers

- [Jogy George](https://www.keypedia.com/people/jogy-george/00ef0915-66d2-4b34-9b74-d1e08caf2db3)
- [Investigator](https://www.keypedia.com/people/andrew-j-idzior/5b639c02-d062-4a5a-aa4a-8362ddfba2b6)

Company: https://www.keypedia.com/companies/lupin-limited/218ee27f-639e-4fc4-995c-345bc58c3548