FDA Compliance
On March 3, 2026, the U.S. Food and Drug Administration (FDA) issued a warning letter to Tentamus India Private Limited. The inspection it describes started the way most do, with one difference. At the initiation of the inspection, the agency’s investigator observed the firm attempting to remove…
At first glance, the next version of RC14001, the management standard for the chemical industry, looks like a simplification. In practice, it gives organizations more flexibility but also more responsibility. The revised standard no longer hands organizations a predefined list of stakeholder…
A quality team’s supplier toolbox is deep. Supplier questionnaires, PPAP, supplier scorecards, incoming inspection, audits, corrective action—the list goes on.
In my years of experience as a quality leader, the challenge I see is matching each one to the right stage in the…
On April 2, 2026, the U.S. Food and Drug Administration issued a warning letter to Purolea Cosmetics Lab, reference 722591-04022026. By now, most of you have heard the story. The company had used AI agents to write drug product specifications, procedures, and master production records. No…
Extreme heat, drought, wildfires, floods, record-low rivers, and rising energy demand have defined much of the summer of 2026. But for businesses, the important story isn’t simply that weather records are being broken. It’s where those physical changes enter the operating system of a company.…
The European Commission’s latest Joint Actions on Compliance of Products (JACOP) project offers a useful starting point for understanding why products can still fail environmental compliance checks even when manufacturers have established compliance programs.
Published in June…