At the conclusion of the inspection, a FDA 483, which is a list of deficiencies observed by the inspection team at the facility, was issued to PCA that identifies a number of good manufacturing deficiencies associated with the firm’s manufacturing process. Specifically, the team identified approximately 12 instances in 2007 and 2008 where the firm, as part of their own internal testing program, identified some type of Salmonella and released a product after it was retested, in some case by a different laboratory. The inspection also identified a number of deficiencies related to the firm’s cleaning programs and procedures for their manufacturing equipment as well as failure to take steps to mitigate Salmonella contamination or crop contamination in the facility. Finally, the inspection revealed environmental samples that were collected during the inspection that tested positive for Salmonella.
During the teleconference, the FDA and CDC reassured the press and public that the FDA, along with its State counterparts, has visited nearly 1,000 firms who purchased products originating from PCA to facilitate the recall of products. The FDA continues to work with CDC, State Officials, and the PCA to test additional peanut-containing products, track additional distribution sources, and review distribution records. So far there are 501 persons from 43 states and one additional person in Canada that have been infected with the outbreak strain of Salmonella typhimurium; of these, 108 or 22% were hospitalized because of the illness and eight deaths have been reported that may be associated with the outbreak. According to Robert Tauxe, Deputy Director, Division of Foodborne Bacterial and Mycotic Diseases, CDC, the outbreak appears to be ongoing and the numbers of new cases have decreased modestly.
FDA/CDC media teleconference transcript download (pdf)
FDA form 483 download (pdf)
The U.S. Food and Drug Administration (FDA) along with the Centers for Disease Control and Prevention (CDC) held a media teleconference on Jan. 27 to update consumers on the Salmonella typhimurium outbreak in peanut butter products. According to Stephen Sundlof, Director, Center for Food Safety and Applied Nutrition, FDA, the agency has concluded its investigation of the Peanut Corporation of America (PCA) facility in Blakely, Ga. This is the plant that the FDA has determined to be the source of the current Salmonella outbreak. That inspection was initiated on Jan. 9, 2009, and the inspection team included FDA investigators, FDA microbiologists, as well as representatives from Centers for Disease Control and Prevention (CDC) and the Georgia Department of Agriculture.