It starts with an unannounced arrival in the lobby. A produce company is operating in full swing at its chopped bag salad plant when investigators with the Food and Drug Administration come calling for a random inspection. For the next two weeks, investigators’ eyes are on everything, pouring through records, food safety plans, collecting samples and making observations.
When their evaluation is complete, a five-page document is handed over to the food company’s senior management with a summary of the inspection. This document, known formally as an FDA Form 483, notes three separate observations recorded during the investigation, highlighting issues with contamination of surfaces, floor and wall construction, and a failure to conduct pest screening.
“Essentially, a Form 483 is like a police officer giving you a speeding ticket,” explains Shawn K. Stevens, food safety lawyer and founding member of Food Industry Counsel, LLC. “It outlines all the violations that the FDA investigators observed while inspecting your facility.”