FDA 483 - Reliance Life Sciences Private Limited - February 27, 2026

An FDA inspection of Reliance Life Sciences Private Limited in Navi Mumbai revealed critical deficiencies across its quality control and manufacturing operations. The firm was cited for significant data integrity issues, including falsified environmental monitoring records and manipulated microbial limit test results for active pharmaceutical ingredients. Additionally, the inspection found inadequate aseptic processing controls, including poor sterilization validation, deficient media fills, and compromised cleanroom practices, alongside a severely lacking deviation management system that failed to investigate equipment malfunctions impacting product quality.