Tuesday, October 27, 2015

Inspection Observations - FDA.gov

Go to this FDA webpage:  Inspections > Inspection Observations - FDA.gov:

"FDA’s Office of Regulatory Affairs (ORA) is the lead office for all field activities, including inspections and enforcement. 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.

Spreadsheets summarizing the areas of regulation cited on FDA's system-generated 483s are available by fiscal year on the menu links on this page. These spreadsheets are not a comprehensive listing of all inspectional observations but represent the area of regulation and the number of times it was cited as an observation on an FDA Form 483 during inspections conducted by FDA and its representatives. Turbo EIR is FDA's automated Form 483 reporting system. Turbo EIR is utilized to generate the FDA Form 483 when applicable cite modules exist. Not all FDA Form 483s are generated in TurboEIR as some 483s are manually prepared and not available in this format. Observations have been broken out by Product or Program Area on separate tabs of the spreadsheet. The Product and Program Areas include the following:

  • Biologics
  • Drugs
  • Devices
  • Human Tissue for Transplantation
  • Radiological Health
  • Parts 1240 and 1250"

'via Blog this'

In fiscal year 2014, you'll notice that biologics and drugs areas were highly associated with some kind of sub-standard investigation.

You might also be interested in this workshop:


Root Cause Analysis for Better Investigations - a cGMP Training Workshop by SkillsPlus Intl Inc.

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