When the U.S. Food and Drug Administration (FDA) shows up to conduct a regulatory inspection, fresh produce food facilities and farms have certain responsibilities to comply – and have rights, too. To help PMA members understand their responsibilities and rights during a regulatory inspection – especially since the
Food Safety Modernization Act (FSMA) expands FDA’s regulatory inspection authority – PMA’s food safety team, in collaboration with the global food- and drug-law firm Keller & Heckman LLP, have developed a trio of new resources including a how-to “Food Regulatory Inspection Manual.”
What’s the likelihood that your business will be inspected? Large manufacturing, processing and warehouse facilities may be subject to annual inspections. If you operate a farm subject to the FSMA Produce Safety Rule, compliance dates and inspections that will follow are right around the corner in January 2018. At this time, it is not clear whether regulators will be using similar or different procedures and practices when inspecting a farm compared to a food facility; however, being prepared for the inevitable inspection is highly recommended.
The guide and related on-demand webinar are based on the premise that the key to a successful inspection is to prepare before FDA knocks. Part of that preparation is to understand what FDA can require from the company being inspected as well as to understand what the company’s rights are. For example, FDA cannot require you to divulge certain confidential business information, or impose undue disruptions on a business. In addition to the Food Regulatory Inspection Manual and the webinar, a handy one-page Do’s and Don’ts Inspectional Checklist provides practical tips on how to make an inspection go smoothly.
Every produce business should take steps to prepare for and successfully complete a regulatory inspection. The risks of failing to do so are potentially severe: product recalls, adverse publicity and business consequences from a facility shutdown, re-inspection fees, criminal prosecution and possibly imprisonment.
The inspection guide, checklist and webinar join a host of resources that PMA has produced to help the fresh produce industry comply with FSMA. The guide and other FSMA resources are posted to the “food safety” topics section of PMA.com.