Laurus Synthesis Private Limited – FDA 483, Dec 12, 2023

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):**