FDA 483 - Alkem Laboratories Ltd - May 01, 2026

The 483 report for Alkem Laboratories Limited details significant deficiencies in quality control, process validation, and complaint handling. The firm failed to thoroughly investigate Out of Specification (OOS) and Out of Trend (OOT) results, leading to delayed recalls and distribution of potentially substandard products. Additionally, issues with data integrity in QC testing, inadequate process validation, and failure to submit Field Alert Reports for repeated complaints were noted, indicating a lack of robust quality oversight.