FDA News

Your shipment arrives at the port. You're excited to finally get your products to market. Then you receive an email from your customs broker: "Your shipment is on hold. Customs is requesting an FDA certificate." Your heart sinks. You don't have an "FDA certificate." You've never heard of one. You call the FDA. They tell you they don't issue certificates. You call your broker back. They're not sure what's happening either. Meanwhile, your inventory sits at the port. Your custo

You receive the email you've been waiting for: the FDA has issued a close-out letter. The violations cited in your Warning Letter have been verified as corrected. The enforcement action is officially closed. You exhale. The nightmare is over. Except it's not quite that simple. An FDA close-out letter creates a dangerous moment for many brands. The relief of closure can mask a critical misunderstanding: a close-out letter does not mean permanent clearance, immunity from future

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...