FDA Issues Summary of Inspection Items Listed on 483 Reports Issued in FY2017

FDA posted the summary of inspectional observation items listed on 483 reports from FY 2017 (10/2016 to 9/2017). 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. "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."

According to the posting, there were 2662 483's issued during FY 2017, compared to 2196 in 2016.    While the top 5 are similar to those listed in 2016, and most issues involve pest control, sanitation, processing concerns, and building  structure issues, there is a new item which is the Failure to Develop a FSVP (Foreign Supplier Verification Program).  The FSVP is for controlling foreign suppliers when a company not operating under Preventive Controls is importing the food.