A Surprise Visit from Inspectors? How to React

Industry and trade associations have been buzzing for months about how FDA and state food-regulatory agencies will implement FSMA’s rules, particularly with the new Good Manufacturing Practices (GMPs) and Preventive Controls rules effective in September. Some inspection activities may be truly different, but preventing and limiting the effects of foodborne disease will not change.

Q: What documentation will regulators expect to see, and can I use my existing HACCP Plan?

Regulatory investigators have attended the Food Safety Preventive Controls Alliance training with industry attendees and will have their own internal regulatory training as well. It’s safe to say that they will expect to see summary forms similar to what was presented in that course which would include:

  • Documented hazard analysis to identify preventive controls that will be monitored similar to a critical control point (CCP) in HACCP:
    • Consideration for known or foreseeable hazards in raw materials, formulations, and site-specific conditions (e.g., building, equipment, sanitation, hygiene) that could allow significant food safety hazards.
    • Evaluation of likelihood and severity of known hazard(s) if an effective preventive control(s) is not in place.
  • Hazard evaluation for environmental pathogens for ready-to-eat (RTE) products, as applicable.
  • Supporting documentation for conclusions made during hazard analysis using illness data, scientific reports, regulatory guidance, or other information.

While you can use any part of your existing food safety plans, process controls, sanitation programs, or other GMP programs as part of your preventive controls for specified food safety hazards, site-specific hazard evaluation still must be part of the evaluation. If there are known food safety issues with your building, equipment, or operational conditions, they should be represented in the hazard analysis, identifying any necessary controls you have in place.

Q: How do we prepare for these regulatory inspections?

Training, training, and more training is the best course of action. With FDA’s expanded powers to review and request food safety records to be delivered within 24 hours, all personnel need thorough training on how to interact with regulators. The preventive control qualified individual (PCQI) will be at the center of those questions, but supervisors and plant employees carrying out and verifying preventive controls are likely to be interviewed to assess the plant’s food safety culture as compared to the GMP conditions observed at the facility. With preparation being key to success, it is advisable to test your readiness by performing an internal mock regulatory inspection or consulting a third-party provider that specializes in GMP compliance.


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