FDA's February Warning Letters Emphasize Preventing The Spread Of Salmonella
By Laurel Maloy, contributing writer, Food Online
During the second month of 2014, The FDA issued nine warning letters to food manufacturers and processors. As FSMA implementation approaches, expect the number of issued warning letters to rise
FDA Warning Letters are issued from a total of 18 U.S. Food and Drug Administration District Offices. Divided into five specific regions of the U.S. — the Northeast, Central, Southeast, Southwest and Pacific Regions. These five FDA Regional Offices serve the interests of all 50 states and a number of U.S. Territories. These 18 district offices utilize state resources to conduct the inspections ensuring food safety and adherence to the regulations administered by the Federal Government. In fact, the letters issued in February were the result of inspections carried out as early as August of last year.
The first FDA Warning Letter issued in February was addressed to Swiss Mountain View Egg Farm, the result of an inspection on August 14-16, 2013. This facility was found to be in violation of the Shell Egg Regulation, Code of Federal Regulations (CFR), Title 21, Sec. 118. Swiss Mountain View was in violation on the production, storage, and transportation of shell eggs in regard to the proactive prevention of Salmonella Enteritidis (SE). It’s interesting to note that this section of the CFR is for facilities with more than 3000 laying hens. The warning letter included the fact that the owner stated he would be reducing the number of laying hens on his farm. This would make it unnecessary for his farm to comply with this particular regulation. The FDA gave the owner 15 days to respond with the specific steps taken in order to correct the violations.
Another February warning letter was also the result of an August 2013 inspection. The FDA issued a warning letter to Bluegrass Dairy and Food on Feb 12. This whey powder manufacturing facility was inspected over the course of two days last August and five days a month later. The warning letter specifies the finding of Salmonella, along with a detailed description of exactly where the organism is located within the plant. This same letter references an inspection done on Jan 29 and 30 of last year where Salmonella was also found. The FDA utilized a Pulsed-Field Gel Electrophoresis (PFGE) to determine the strain of salmonella was the same in both instances. The warning letter further suggests the sanitation procedures utilized to eliminate the organism after the first January inspections should be reevaluated. The FDA made clear there was a high risk of food contamination due to four locations in the plant where Salmonella Seftenberg was found. Again, Bluegrass Dairy and Food was given the standard 15 days to reply.
It is interesting to note that none of the February FDA Warning Letters issued a specific closing date. However, standard practice is for the FDA to request response within 15 working days from the receipt of the letter. The response is required, in writing, and must outline the steps that will be taken or are currently being taken to correct the stated violations. The violator should include any documentation necessary to show the problem is, or is in the process of being fixed. If compliance is not possible within the prescribed time frame, the reason for the delay must be presented, as well as an estimated time frame for completion.