FDA News

When the FDA arrives, it’s a different ballgame than what you learned in compliance courses. Standard training provides the rulebook but overlooks the unwritten elements, including the strategic and psychological aspects that make or break an inspection. Preparing for the FDA doesn’t have to be a frantic scramble. By embracing a culture of readiness, you can face your next inspection with confidence. Here are 7 practical tips that compliance courses often overlook. 1. Tell a

The moment your business becomes public enemy number one—and the strategic moves that can save your company from regulatory destruction. Three weeks ago, a cosmetics CEO called us in a panic. "We just got something from the FDA," she said. "It's posted on their website. Our biggest retailer is asking questions. What do we do?" She'd received an FDA warning letter. Not a Form 483 . Not an inspection observation. A full-blown, public, formal enforcement document that essentiall

The moment your business becomes public enemy number one—and the strategic moves that can save your company from regulatory destruction. Three weeks ago, a supplement company CEO called me in a panic. "We just got something from the FDA," he said. "It's posted on their website . Our distributors are pulling our products. What do we do?" He'd received an FDA warning letter. Not a Form 483 . Not an inspection observation. A full-blown, public, formal enforcement document that e

The critical mistakes that turn routine FDA observations into business-threatening crises—and the strategic response that protects your...