# FDA WARNING_LETTER - Unexo Life Sciences Private Limited - May 14, 2024

Source: https://www.globalkeysolutions.net/records/warning_letter/unexo-life-sciences-private-limited/0bdc6157-bfd2-4bad-b0ac-c9ecd5aa968e

> FDA WARNING_LETTER for Unexo Life Sciences Private Limited on May 14, 2024. Product: Drugs. Access full analysis and detailed observations.

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## Details

- Record Type: WARNING_LETTER
- Company Name: Unexo Life Sciences Private Limited
- Inspection Date: 2024-05-14
- Product Type: Drugs
- Office Name: Center for Drug Evaluation and Research
- Summary: The FDA issued a Warning Letter to Unexo Life Sciences, Private Limited, following an inspection from May 1-14, 2024, identifying significant CGMP violations, rendering their drug products adulterated.

Key violations include:
1.  **Quality Control Unit Failures (21 CFR 211.22):** The firm's quality control unit failed to ensure CGMP compliance and data reliability.
    *   **Incomplete Batch Records (21 CFR 211.188):** Torn and missing batch production records were found, and executive management admitted to retrospectively preparing records for U.S. market products. The firm's response was inadequate, lacking detail on detecting non-contemporaneous records and a rationale for only destroying select batches.
    *   **Incomplete Laboratory Records (21 CFR 211.194(a)):** Raw data for product testing, including assay and peel strength, was missing for released drug products. The firm's response was inadequate, lacking a detailed investigation plan for incomplete records and sufficient detail on data integrity detection.
    *   **Inadequate Computer System Controls (21 CFR 211.68(b)):** A QC analyst could manipulate results, dates, and images on COAs from third-party labs. The firm's response was inadequate, failing to detail how appropriate controls and user privileges would be implemented.

## Related Documents

- [483 - 2024-05-14](https://www.globalkeysolutions.net/records/483/unexo-life-sciences-private-limited/96eac3cd-91e4-4221-aa88-2d6fee3e654f)

## Related Officers

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

Company: https://www.globalkeysolutions.net/companies/unexo-life-sciences-private-limited/0a2a6fc8-1ef3-46dc-a2ca-f4eb344630e3

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