We inspected your manufacturing facility, located at 2339 Center Square Road, Swedesboro, NJ 08085 from July 27 through August 23, 2012 in response to a report from US Army Public Health Command that a sample of your apple slices yielded Listeria monocytogenes (Lm). During this inspection, finished product, investigational, and environmental samples were collected from your processing facility. A sample of diced and a sample of sliced apples yielded Lm. Consumption of food contaminated with Lm can result in a mild illness (called Listerial gastroenteritis) or a severe, sometimes life-threatening, illness called invasive listeriosis. Immune-compromised individuals and unborn fetuses are particularly susceptible to listeriosis. Accordingly, these apple products are adulterated within the meaning of 402(a)(1) the Federal Food, Drug, and Cosmetic Act (the Act) [21 U.S.C. § 342(a)(1)] in that they bear or contain a poisonous or deleterious substance which may render them injurious to health.

In addition to the aforementioned finished product samples, Lm was detected on food contact surfaces and non-food contact surfaces in the apple processing room, and in samples of ascorbic acid dip solution. A total of 27 Lm environmental subsamples collected during the inspection yielded Lm. These isolates were indistinguishable as analyzed by PFGE analyses from isolates taken from finished product samples. The presence of PFGE indistinguishable Lm isolates in the environment, food contact surfaces, and finished product samples is indicative of cross contamination as well as harborage problems. Accordingly, products manufactured in your facility are adulterated under 402(a)(4) of the Act [21 U.S.C. § 342(a)(4)], in that, they have been prepared, packed, or held under insanitary conditions whereby they may have become contaminated with filth, or whereby they may have been rendered injurious to health.

We acknowledge that you have voluntarily recalled all apple products that were produced in your facility between July 8, 2012 and August 20, 2012 and that you have stopped apple product production at the 2339 Center Square Rd. location.

We received your written response, dated September 5, 2012 indicating that you will develop and implement a redesigned Listeria Control and Monitoring Program by September 8, however, you have not provided any further details of this program or supporting documentation to New Jersey District as evidence of its implementation.

The response also states that you have abandoned the (b)(4) in favor of a (b)(4), including (b)(4), for the new and redesigned apple processing facility; however, you did not provide documentation of the efficacy of the new process in controlling Lm.

Furthermore, you identify the source of the Lm contamination as the “(b)(4),” but you do not mention any corrective actions taken to correct the (b)(4) that you identified as “not designed or constructed in a manner that would allow for adequate dismantling, cleaning and inspection.” During the inspection it was noted that you were moving certain pieces of apple processing equipment to your new processing facility. A firm representative stated that the equipment would be tagged and environmentally sampled prior to being moved to the new facility to ensure that no Lm remained. The results of this sampling were not provided with your response.