FDA 483 - KENIL HEALTHCARE PRIVATE LIMITED - December 11, 2024

Kenil Healthcare Private Limited, a drug manufacturer in Ta. Kadi, India, was cited for numerous significant deficiencies during an FDA inspection. The firm demonstrated a severe lack of quality control oversight, including failures in process and cleaning validation, annual product quality reviews, deviation management, and batch record completion. Additionally, critical issues were identified in employee training, equipment maintenance, facility sanitation, laboratory controls, and stability testing, indicating a systemic breakdown in cGMP compliance.