FDA focus and plans for FSMA inspections…

Large companies (more than 500 employees) were required to be in compliance with the first parts of the rule in September 2016. What did that mean in terms of FDA inspections? As one might expect, it has been a slow start and there have not been inspections to date. The FDA is focused on training inspectors (31 had been trained as of early December 2016). They are working with states to contract inspections as well and we expect that New York and Pennsylvania will do so. So what are they doing? FDA Consumer Safety Officer Jenny Murphy spoke at a conference held by AFIA in Arlington, VA in early December. She spoke about the inspection efforts by the FDA and what to expect moving forward.

Key points made:

  • Only inspections in FY17 will be for compliance with CGMPs for “large” businesses
  • Other facilities that get inspected (for BSE or medicated feed CGMPs) can expect to be asked FSMA readiness/awareness type questions. Answers are voluntary but very helpful to FDA staff.
  • Inspections expected to start January 2017
  • FDA will NOT inspect all “large” businesses in first year

She answered the following questions:

  • Does the focus on education mean the FDA will NOT hold companies to these standards right away? No, while the focus is on education a public health threat will move inspections to action.
  • What is the best thing a facility can do to prepare? Take the intent of the rule to heart, look at big picture and look past the regulation… Document, document, document!
  • Where can companies go wrong in preparing? By putting the focus on passing the inspection and NOT putting food safety in the forefront.
  • What is the ultimate goal of the FDA? The ultimate goal is food safety and public health.