• Are you regulated by the US FDA?
    Know what to do before, during and after an inspection.
  • Preparation for FDA Inspections
    Be ready and in compliance when the FDA inspects your facility.
  • Inspection Remediation
    Post-Inspection FDA-483 Strategies

Negative inspection findings on an FDA-483, or   regulatory actions like warning letters, debarment, consent decrees, seizures and injunctions can have a serious impact on your FDA regulated company. Therefore, it’s critical to stay up to date and in compliance with FDA laws, regulations, and guidelines.

The US Food and Drug Administration (FDA) inspects facilities to confirm their compliance with agency regulations to protect the health of the public. FDA Inspections are performed on everything from pharmaceuticals and cosmetics to medical devices and food, to assure the product’s quality and safety.