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Document Control Nightmares: Common Mistakes That Trigger 483 Observations
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
Evelyn Rodriguez Gomez
May 17, 202517 min read
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