Regulatory Compliance

If you've ever reviewed FDA 483 observations or warning letters, you've noticed something: document control issues are everywhere. They show up in medical device inspections, pharmaceutical manufacturing audits, laboratory GLP inspections, and every other regulated industry the FDA oversees. The reason document control failures are so common isn't that they're technically difficult to prevent. It's that document control touches literally everything your organization does - ev

If you've spent any time reviewing FDA warning letters, you've probably noticed a pattern: supplier-related issues show up everywhere. Incoming materials that don't meet specifications. Components with undisclosed changes. Test results from unqualified laboratories. Suppliers who can't demonstrate their own quality systems are adequate. The FDA's FY2024 Report on the State of Pharmaceutical Quality drove this point home. Over the past five years, 72% of regulatory actions aga

If you assumed FDA inspections would eventually go back to the way they were before COVID, think again. The shift toward hybrid and remote inspections that started during the pandemic has become a permanent part of how the FDA conducts oversight - and it's having a bigger impact on warning letters than most organizations anticipated. In FY2024, remote information requests or failures to respond to them accounted for nearly a quarter of all warning letters issued by the FDA. T

If there's one area of your quality management system that FDA inspectors scrutinize most closely, it's your CAPA program. Year after year, corrective and preventive action remains one of the top citations on FDA Form 483 observations and warning letters. And yet, most organizations treat CAPA like a checkbox exercise rather than the problem-solving system it's supposed to be. The result? Recurring nonconformances, repeat findings during inspections, and warning letters that

The clock is ticking. On February 2, 2026, the FDA's new Quality Management System Regulation (QMSR) becomes mandatory for all medical device manufacturers. If your organization is still operating under the old Quality System Regulation (21 CFR Part 820), you have just over one year to complete your transition. This isn't a minor regulatory update - it's the most significant change to FDA quality requirements in nearly 30 years. The FDA QMSR replaces 21 CFR Part 820 with ISO