# FDA WARNING_LETTER - Shilpa Medicare Limited - February 25, 2020

Source: https://www.keypedia.com/records/warning_letter/shilpa-medicare-limited/2e18f8c2-80a9-409d-a285-427792df7cb5

> FDA WARNING_LETTER for Shilpa Medicare Limited on February 25, 2020. Product: Drugs. Access full analysis and detailed observations.

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## Details

- Record Type: WARNING_LETTER
- Company Name: Shilpa Medicare Limited
- Inspection Date: 2020-02-25
- Product Type: Drugs
- Office Name: Center for Drug Evaluation and Research
- Summary: The FDA inspected Shilpa Medicare Limited, Unit-IV, from February 13-25, 2020, identifying significant CGMP violations for finished pharmaceuticals, rendering their drug products adulterated under 21 U.S.C. 351(a)(2)(B).

Key violations include:
1.  **Inadequate Investigations (21 CFR 211.192):** Failure to thoroughly investigate OOS results and complaints.
    *   **OOS for Impurity:** An OOS result for impurity-(b)(4) in (b)(4) Tablets batch (b)(4) was inadequately investigated. The firm failed to identify a root cause, attributed an unknown chromatographic peak without support, and retested batches without including the original OOS batch.
    *   **OOS for Assay:** Three batches of (b)(4) Injection showed OOS assay results. The firm concluded analytical error without sufficient scientific justification and released batches based on retest results, with inadequate CAPA details.
    *   **Complaint Investigation - Sealing Defects:** An inadequate investigation for (b)(4) Injection batch (b)(4) where the enclosure separated from the vial, despite an unplanned deviation during manufacturing due to sealing defects. The batch was released without justification.
    *   **Complaint Investigation - Foreign Particles:** Multiple complaints for foreign particles in (b)(4) Injection were inadequately evaluated.

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## Related Officers

- [Director](https://www.keypedia.com/people/francis-godwin/1556d203-d47c-4744-af37-2591a163149e)

Company: https://www.keypedia.com/companies/shilpa-medicare-limited/9184777f-89bb-4a33-bcb2-4cc2aa4eb655

Office: https://www.keypedia.com/offices/center-for-drug-evaluation-and-research/cd980d74-1cbf-4226-ba9a-9045324c236c