Craig S. Schwandt
Food Quality & Safety - November 19, 2015
Although the Food Safety Modernization Act (FSMA) was signed into law in January 2011, revisions to many of the regulations delayed their implementation. Recently, the FDA established several of the final rules for compliance and activated them in August and October 2015. These include preventive controls for human food and animal feed, produce safety, Foreign Supplier Verification Program (FSVP), and third-party accreditation and certification. Compliance with the regulations is required within 18 months to two and a half years depending on the specific regulation. But what do FDA auditors really expect to see when they visit your business?
The FDA’s primary concern is ensuring that companies are following the regulations and therefore sends auditors to inspect the compliance records that companies keep, or may soon have to start keeping. The records demonstrate that the requisite steps were taken to meet compliance with the regulations. With regard to identification of contaminants, some food manufacturers may have to significantly augment their practices. Specifically, greater use of forensic or investigational analysis will be required. For example, food companies that obtain any portion of their product from outside of the U.S., whether whole or ingredients, will be subject to FSVP regulations. FSVP regulations require companies to investigate the origin of contaminants that may occur in their product. Under FSVP, the FDA will want to see the records for all stages of testing, including establishing the origin of contaminants. Although bulk analyses are great at establishing the presence of contaminants, bulk methods are not particularly good at identifying the what, when, and where of contamination; answering these questions typically requires forensic or investigational analysis methods. Maintaining the records from all stages of the investigation is vital for a successful positive outcome FDA audit.