Major developments in the Food Safety Modernization Act (FSMA) have given the FDA new authority under the law. If the FDA decides to conduct a swabathon at your facility, you should expect a minimum of 100 to 300 swabs to be taken and a team of several investigators to conduct the swabathon. Based on the type of swabathon, you may also be required to hold production in your facility. This need is based on several factors, but, in particular, the zones that will be tested.
The FDA’s goal is to find pathogen isolates of Salmonella and or Listeria monocytogenes in and around the processing environment. As an outcome, the FDA will subsequently perform Whole Genome Sequencing (WGS) on these Listeria monocytogenes isolates for their database. The FDA is now swabbing Zone 4 specifically for this purpose, with a WGS analysis of Salmonella expected to follow. The FDA’s zone focus will differ based on the environment and the specific pathogen they are seeking out. For Listeria monocytogenes, you can expect the FDA to begin sampling no sooner than 4 hours into production. Continue Reading