In FDA Regulated industries, the goals are to:
1 - Reduce product risk
2 - Increase quality
3 - Minimize regulatory enforcement actions
4 - Keep patients safe
FY 2017 Inspectional Observation Summaries
Number of 483s Issued from the System*
Inspection ending between 10/1/2016 and 9/30/17
*This table does not represent the complete set of 483s issued during the fiscal year as some 483s were manually prepared and not available in this format. The sum of 483s for all Product Areas will be greater than the actual Total 483s issued during the fiscal year since a 483 may include citations related to multiple product areas, and counted more than once, under each relevant product centers.
**This is the Actual Total number of 483s issued from this system, and that are represented in this spreadsheet.