# FDA 483 - Laurus Synthesis Private Limited - December 12, 2023

Source: https://www.keypedia.com/records/483/laurus-synthesis-private-limited/c1b44afb-2609-4100-960b-287be6b331e4

> FDA 483 for Laurus Synthesis Private Limited on December 12, 2023. Product: Drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Laurus Synthesis Private Limited
- Inspection Date: 2023-12-12
- Product Type: Drugs
- Office Name: Center for Drug Evaluation and Research
- Summary: The FDA inspection identified significant deficiencies in the facility's quality system and manufacturing processes, particularly concerning investigations, sampling, equipment maintenance, batch records, and document control.

**Key Violations and Observations:**

*   **Inadequate Investigations (Observation #1):**
    *   Investigations into five instances of (b)(4) damage over three years were deficient. Issues included failure to document damage size/location, insufficient screening of potentially impacted batches for (b)(4) particles (e.g., DEV-SVI-22-0002, DEV-SVI-23-0002), and lack of scientific justification for downstream filtration's ability to remove contaminants.
    *   Non-conformance investigation (NCM/LSVI/003/22) for assay/purity failures was inadequate, concluding "isolated case" without further action.
    *   OOS investigation (OOS/LSVI/001/22) for impurity identified improper in-process sampling, but the sampling procedure (MFG/027) was not specific, and the (b)(4) material's distribution was not scientifically justified.
    *   Non-conformance investigation (NCM-LSVI-001) for OOS (b)(4) water TOC did not correlate with other test results.

*   **Inadequate Sampling Plans (Observation #2):**

## Related Documents

- [483 - Unknown Date](https://www.keypedia.com/records/483/laurus-synthesis-private-limited/8b368319-e97e-48ce-adcc-40fe7a9d6bd7)

## Related Officers

- [Joseph A. Piechocki](https://www.keypedia.com/people/joseph-a-piechocki/1977a57b-4976-4b01-b8da-66a84b26e803)
- [Investigator](https://www.keypedia.com/people/rafeeq-a-habeeb/ac58c0b7-bd42-4037-8ccb-bf0351b7744f)

Company: https://www.keypedia.com/companies/laurus-synthesis-private-limited/363bc2da-6251-4991-acfd-ff4949afe353

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