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Ten Most Common Reasons for FDA 483 Inspectional Observations in Pharmaceutical Environments

The U.S. Food and Drug Administration (FDA) issues Form 483 Inspectional Observations or warning letters when communicating to a pharmaceutical company that its quality practices are not in compliance with regulatory standards. Most of these observations and warnings are due to some form of the following infractions:

  • No established procedures that conform to FDA standards in one or more regulated areas;
  • Established procedures conform to FDA standards, but are not followed according to regulations; or
  • Procedures conform to FDA regulations and are followed, but are inadequately documented and do not prove the organization is within compliance parameters.

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