Get Ready for an FDA Audit

Large food manufacturers have recently experienced the first taste of the U.S. Food and Drug Administration’s Food Safety Modernization Act (FSMA). As of September 19, 2016, large businesses (500 or more employees) with human food facilities had to comply with new standards around preventative controls and current good manufacturing practices (CGMP). Small food manufacturers will have until September of this year to comply, followed by several more final rules for the foreign supplier verification program (FSVP), sanitary transportation of food, and food defenses around intentional adulteration.

While manufacturers focus on creating a hazard analysis and risk-based preventive controls (HARPC) plan, it is critical to the future health of these organizations to understand what the FSMA guidance says and what Food and Drug Administration (FDA) inspectors will be looking for during plant audits. To that end, this is not just a management or technology issue, but a business matter that requires engagement with a company’s legal department.

That was the message delivered by Elizabeth Fawell, counsel at legal firm Hogan Lovells. Fawell specializes in food regulations and was a presenter at the ProFood Tech conference in Chicago this week. The FDA could be knocking on any plant-floor door to conduct an audit, an exercise that includes reviewing records, taking product samples to detect pathogenic contamination and collecting evidence that could be used against the company. If, when inspectors walk out, you are handed a Form 483 report—which outlines violations—it could spell trouble for the company. And, for the record, the FDA is not shy when it comes to calling out violations. In the FDA’s fiscal year 2016 Inspectional Observational Summaries, there were 2,196 Form 483 reports given to food companies.

Understanding that the FDA could be coming your way, it is important to engage with the company’s legal department early on. “You don’t want to get a warning letter and that’s the first time general counsel knows you had an inspection,” Fawell said. “They need to know when an inspection is conducted so they can respond to a 483.” Similarly, plant managers and their team must be well-versed on the company’s food safety plan, which means being able to discuss procedures and scientific justification in detail. “And know what records to pull. A lot of folks will have all the documentation but when the FDA says ‘let’s see the procedures for the metal detector,’ they don’t know exactly what to pull. You need to have that mapped out ahead of time.”