Pharma Talk

A recent FDA inspection at a U.S. drug company—making products like pain relief gels and fluoride toothpaste—has uncovered serious problems ...

The United States Pharmacopeia (USP) General Chapter <1221> Ongoing Procedure Performance Verification, proposed in the Pharmacopeial ...

To conduct a **gap assessment** between the **old Schedule M** and the **revised Schedule M** of the **Drugs and Cosmetics Rules, 1945**, we...

On June 6, 2025, the U.S. Food and Drug Administration (FDA) sent a stern warning letter to Horizon Tool Inc., a Greensboro, North Carolina-...

Here’s a rewritten and detailed version of the FDA Warning Letter topic for your blog: --- 🧪 “Memory‑Based Manufacturing” and the Critical ...

The U.S. Food and Drug Administration (FDA) issued a Warning Letter to AACE Pharmaceuticals, a U.S.-based company, on April 9, 2025, followi...

In the pharmaceutical industry, maintaining high-quality standards is critical to ensuring safe and effective products. A key component of t...

The company experienced seven out-of-limit (OOL) events for microbial content in a system used to generate a major component of drug product...