White Paper

10 Reasons for FDA 483 Inspectional Observations

Ten Most Common Reasons for FDA 483 Inspectional Observations in Pharmaceutical Environments
What's Included:
  • The most common reasons the FDA has issued Form 483 Inspectional Observations.
  • How an enterprise quality management system (EQMS) can help pharmaceutical companies avoid the Form 483.
About This Asset

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 caused by the same 10 common mistakes, download the whitepaper to learn more about the common reasons for the warning letters.

Most Common Reasons for FDA 483 Observations


Procedures not in writing or fully followed

Problems and accidents are inevitable if the employees of a pharmaceutical product research organization and/or manufacturer do not have current written instructions for their tasks.


Laboratory controls not scientifically sound

To maintain the integrity of laboratory controls, a company must have a system in place that effectively integrates quality processes such as those critical to change control, audits, and CAPAs.


Discrepancies and/or failures in investigations

If a pharmaceutical company is unable to identify potential root causes and make sufficient record of them, their internal investigations will be viewed by the FDA as incomplete.

Learn How to Avoid an FDA 483 Warning Letter

Don't make these 10 common mistakes.

Download the Whitepaper
[ { "key": "fid#1", "value": ["Everything else"] } ]