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
Center Name
483s Issued
Biologics
115
Bioresearch Monitoring
243
Devices
1030
Drugs
694
Foods
2662
Human Tissue for Transplantation
61
Parts 1240 and 1250
75
Radiological Health
31
Veterinary Medicine
244
Sum Product Area 483s from System*
5515
Actual Total in System 483s**
5045
*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.
Picture