On June 6, 2013, the U.S. Food and Drug Administration (FDA) sent a warning letter to Ms. Fina Serra, co-owner and manager of S. Serra Cheese Company in Clinton Township, Michigan. The letter explained that FDA found excessive levels of E. coli in three finished product samples that were collected during a facility inspection in January 2013. During the inspection, FDA also found Listeria innocua, an indicator of unsanitary conditions, in the facility. Along with the findings, FDA inspectors witnessed multiple serious violations of the Good Manufacturing Practice regulation for foods.
After explaining the facility’s violations, the letter warned that FDA may take further action if the violations were not quickly corrected. However, subsequent inspections revealed the cheese company was still not in compliance with the Good Manufacturing Practice regulations. So, per request of FDA, the U.S. Department of Justice filed a complaint for permanent injunction against S. Serra Cheese Company on August 8, 2014. The complaint requests that the company be prohibited from receiving, preparing, packing, holding, or distributing food until the company brings their operations into compliance. Registrar Corp Executive Director Russell Statman said, “In all likelihood, the court will order the facility to be shut down until the manufacturer takes sufficient corrective action to FDA’s satisfaction.”
Ignoring an FDA warning letter can lead to serious consequences. If a food facility is issued a warning letter from FDA, they need to take immediate action to resolve the issues at hand. Registrar Corp, an FDA consulting firm, can assist food facilities in complying with FDA regulations. We can help develop a Hazard Analysis and Food Safety Plan or review a company’s existing one for compliance and effectiveness. We review product labels, and even offer mock FDA inspections to help prepare.
For compliance assistance or questions about U.S. FDA food regulations, contact Registrar Corp at 1-757-224-0177 or receive online Live Help 24/7 from our regulatory specialists: https://www.registrarcorp.com/livehelp.