FDA 483 - Sri Krishna Pharmaceuticals Limited - June 27, 2025

The FDA inspection of Sri Krishna Pharmaceuticals Limited in Hyderabad, India, uncovered significant deficiencies across quality control, process validation, and data integrity. The firm failed to reject contaminated components, concealed critical documents, and demonstrated systemic failures in investigating Out-of-Specification and Out-of-Trend results. These issues highlight a pervasive lack of adequate procedures and oversight, raising concerns about drug product quality and safety.