USFDA Warning Letter to Hikal Limited | Full Summary & Key GMP Observations Explained

Описание: USFDA Warning Letter to Hikal Limited | Full Summary & Key GMP Observations Explained
In this video, we provide a detailed explanation of the USFDA Warning Letter issued to Hikal Limited, Jigani, Karnataka, following the FDA inspection conducted in February 2025.
The inspection identified multiple Current Good Manufacturing Practice (CGMP) deviations related to:
Inadequate investigation of metal contamination in APIs
Ineffective Corrective and Preventive Actions (CAPAs)
Poor supplier qualification and monitoring system
Weak root-cause analysis and documentation practices
The FDA also directed Hikal to conduct a comprehensive quality system review, enhance supplier oversight, adhere to ICH Q7 guidance, and engage a qualified CGMP consultant to assist in restoring compliance.
👉 Watch till the end to understand each major observation, FDA expectations, and possible regulatory consequences.
📘 Reference:
USFDA Official Warning Letter – https://www.fda.gov/media/71518/download
⚠️ Disclaimer: This video is for educational and informational purposes only. All information is sourced from the official USFDA website.
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