Get Ready for an FDA Audit

April 5, 2017
A regulations and food safety track at ProFood Tech outlined what manufacturers can expect from a Food and Drug Administration inspection that will determine compliance with the Food Safety Modernization Act.

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.”

There are many open questions about pending regulations that remain, such as the verification of the suppliers’ suppliers or the definition of an “importer” for FSVP purposes, so it is important to have the team stay on top of FDA movements. For example, last year the FDA initiated a team called Strategic Coordinated Oversight of Recall Execution (SCORE), a cross-functional team of senior FDA leaders who will address challenging recall situations and speed up response when foods represent a danger to consumers’ health. Why watch this team? Because they are expanding their scope to preventative control inspection. “We need to prepare for quick responses and understand this team—who is on it and what their role is in making and enforcing decisions,” Fawell said.

Keep in mind technological advances as well, like whole-genome sequencing, which enables precise matches between product samples and ill patients. Regulatory agencies are building databases of illness strains found in consumers, “which means it will be increasingly easy to link a company’s products and factory environment to foodborne illness,” she said.

Fawell continued to stress that the FDA will expect a plant manager to explain the scientific justifications underlying the food safety plan and provide supporting documentation. This means the plant manager will be held accountable and must build a team of people who can step in when there are multiple investigators conducting inspections on site performing a “swab-a-thon” search for pathogens via microbiological sampling.

While there are many unknowns in this process, the best way to prepare for inspections is to know your rights, including the company policies and procedures and what the state law says. In addition, Fawell recommends applying good record-keeping practices, preparing for system-based inspections and understanding updated manufacturing processes. Don’t overlook good manufacturing practice (GMP) and create a food safety culture at the company in which all employees understand their role.

“Inspections are changing and will change more as FSMA ramps up,” Fawell said, “and inspectors are eager to use their authority. Keep calm and get ready.”