The cosmetics industry is going through a period of regulatory change. With the Modernisation of Cosmetics Regulation Act (MoCRA) now in force, FDA oversight of cosmetics facilities is sharper than ever. Recent FDA warning letters show that many companies producing cosmetics and over-the-counter (OTC) drug products are still struggling to meet basic compliance expectations. By looking at recent cases, we can see recurring themes: weak testing practices, inadequate quality ov

In the pharmaceutical industry, nothing is more important than quality. It underpins patient safety, product efficacy, and trust in healthcare systems worldwide. Pharmaceutical quality isn't limited to the final product, it also includes the systems, controls, and culture that ensure medicines are made consistently and safely. With regulators raising expectations and global competition intensifying, understanding the core principles of pharmaceutical quality has never been mo

The U.S. Food and Drug Administration (FDA) has been steadily increasing its oversight of global active pharmaceutical ingredient (API) manufacturers. Recent warning letters issued in early 2025 to firms paint a consistent picture of recurring compliance failures, and they reveal exactly where the FDA is focusing its attention. Across four facilities, inspectors documented a pattern of weak quality systems, poor contamination controls, and lapses in data integrity. These find