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

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.