Summary of FDA 483 Inspectional Observations

The U.S. Food and Drug Administration FDA is frequently publishing summaries of its inspection observations listed documented on an FDA Form 483.

FDA's lead office for all field activities, including inspections and enforcement is the Office of Regulatory Affairs (ORA). During an inspection, ORA investigators may observe conditions they deem to be objectionable. These observations are listed on an FDA Form 483 when, in an investigator's judgment, the observed conditions or practices indicate that an FDA-regulated product may be in violation of FDA's requirements. 

Summaries of FDA Form 483s are issued from the TURBO EIR System including the number of times an area of regulation was cited as an observation by product or program area.

In the fiscal year 2010, the most GMP observations were made in the area of written procedures, like for example

• Procedures not in writing, fully followed (21 CFR 211.22(d))
• SOPs not followed / documented (21 CFR 211.100(b))

Also a lot of citations were made with respect to training (21 CFR 211.25(a)). Here it was criticised that employees have not been trained in the particular operations they perform or in current good manufacturing practices.

Wolfgang Schmitt
CONCEPT HEIDELBERG (a service provider entrusted by the ECA Foundation)