by Dr. Yashashwini Reddy | Sep 26, 2025
📌 Case Study: Sun Pharma / Caraco (US) – Recalls due to Contamination and CGMP Non-Compliance Background Caraco Pharmaceutical Laboratories, a US-based generic manufacturer and subsidiary of Sun Pharma, came under FDA scrutiny due to multiple quality issues. As one of...
by Dr. Yashashwini Reddy | Sep 26, 2025
📌 Case Study: Ranbaxy Laboratories – Data Falsification & GMP Violations Background:Ranbaxy Laboratories, once India’s largest generic drug manufacturer, faced one of the biggest regulatory scandals in the pharmaceutical industry. In 2013, the company admitted to...
by Dr. Yashashwini Reddy | Sep 24, 2025
Case Study: Tylenol Cyanide Crisis (1982) Background Johnson & Johnson’s Tylenol was a leading over-the-counter (OTC) pain reliever in the U.S. In 1982, an incident shocked the pharmaceutical industry and the public health system, raising questions about drug...
by Dr. Yashashwini Reddy | Sep 24, 2025
Case Study: Valsartan Recall (2018) Background Valsartan is an angiotensin II receptor blocker (ARB) widely prescribed for hypertension and heart failure. In July 2018, several regulatory agencies, including the USFDA, EMA, and Health Canada, announced recalls of...
by Dr. Yashashwini Reddy | Sep 16, 2025
1.0 Purpose To establish a procedure for the safe, compliant, and documented disposal of expired finished goods in order to prevent unintended use, ensure environmental safety, and maintain regulatory compliance. 2.0 Scope This SOP applies to all expired, damaged, or...
