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    FDA Inspections: Rights and Reasonableness

    When it comes to FDA inspections, it’s rules, and the new rules for the Food Safety Modernization Act's (FSMA) inspections, what are the core rights and responsibilities of your facility?

    Review: FY 2014 Inspectional Observation Summaries

    At the end of each fiscal year the US FDA posts a summary of the Inspectional Observations from Form 483. The fiscal year for the FDA begins October 1 and concludes on September 30. The fiscal year summary provides an excellent opportunity to review the enforcement activities and interests of the FDA. In comparing the observations made from fiscal year to fiscal year trends emerge that allow facilities to prepare for a facility inspection. This year, as with most, the top ten observations remain largely unchanged. FY 2014 did note a marked increase in the number of food facility inspections as can be seen in the graph below.