Description:

For operators of facilities that manufacture or store U.S. Food and Drug Administration-regulated food products, an FDA inspection of these facilities is inevitable. And in light of increased public and legislative focus on food safety issues, the frequency of inspections is likely to increase in the coming years. While regulatory compliance is paramount for a successful inspection outcome, knowledge of the inspection process and preparation of strategic players can reduce anxiety and limit errors associated with inspections. GMA’s Guide to Inspections of FDA-Regulated Food Facilities contains considerable information that will assist facility managers as they prepare for, participate in and properly respond to FDA inspections that now will also be shaped by the Food Safety Modernization Act (FSMA).* Topics covered in this new, comprehensive publication include:

• FDA authority to take photographs
• FDA general authority to access records
• Access to specific records, HACCP and non-HACCP related
• Tools to prepare for an inspection
• SOPs to deal with government inspections
• Response to inspections
• The Establishment Inspection Report
• FDA’s Inspection Operations Manual
• Copying of records
• Sampling during inspections
• Dual jurisdiction