Shiva Analyticals Private Limited Warning Letter Details

Summary

Shiva Analyticals Private Limited, a contract testing laboratory in India, was cited for significant Current Good Manufacturing Practice (CGMP) violations related to finished pharmaceutical drugs during an FDA inspection in January 2025. The facility failed to thoroughly investigate out-of-specification (OOS) test results and batch failures, instead invalidating OOS results without adequate scientific rationale or root cause analysis, in violation of 21 CFR 211.192. The firm also failed to implement effective corrective and preventive actions (CAPA) to address recurring human errors that contributed to these testing failures. These compliance gaps rendered the drug products tested by the facility adulterated under the Federal Food, Drug, and Cosmetic Act.