Thermo Pac, LLC—SimplyThick— Processing Deficiencies

Thermo Pac LLC

Thermo Pac LLC, a processor of hot fill, liquid and dry powder products for the US Department of Defense, Phagia-Gel Technologies (SimplyThick) and various unpublished food companies, became a manufacturer of FDA interest following MedWatch reports linking the SimplyThick product to infant necrotizing enterocolitis.

The FDA—May 20, 2011— SimplyThick Advisory:

Illnesses have been reported from at least four different medical centers around the country. The illnesses of which FDA is aware involve premature infants who became sick over the past six months. SimplyThick was added to the feeding regimen of those infants who later developed NEC to help with swallowing difficulties stemming from complications of premature birth. FDA first learned of adverse events possibly linked to the product on May 13, 2011. To date, the agency is aware of 15 cases of NEC, including two deaths, involving premature infants who were fed SimplyThick for varying amounts of time. The product was mixed with mothers’ breast milk or infant formula products.

September 18, 2012 FDA SimplyThick Infant Health Risk Warning

Since May 2011, the agency has identified 22 infants who developed necrotizing enterocolitis (NEC), a condition in which tissue in the intestines becomes inflamed and dies, after being fed SimplyThick. Seven of those infants died. Infants of any age may face an increased risk of developing a life-threatening condition if fed a thickening product called SimplyThick.

FDA Thermo Pac May 23-June 3, 2011 Inspection (Form 483) Findings

Companies receiving Forms 483 are considered to be in significant violation of federal regulations because aberrant manufacturing practices are threats to public health.

The FDA found that Thermo Pac, an acidified food processor, neglected to notify the agency of new products entering the marketplace, had failed to engage a recognized Processing Authority to approve product pH safety parameters and did not employ certified "acidified food" supervisory staff. During the course of investigation the FDA inspector found evidence of bacillus cereus in eleven SimplyThick finished products and one xanthan gum raw sample.

Contracting parties: John L. Holahan SimplyThick president, and Dennis Straub Thermal Pac Chief Operation Officer agreed that ST products manufactured from June 1, 2009-June 3, 2011 would be recalled. Another, Thermo Pac customer's product (redaction) was also recalled.

John Holahan notified the FDA on June 29, 201l, that he intended to resume SimplyThick shipments for products manufactured after June 4, 2011.

Thermo Pac Deficiency Acknowledgments:

Specifically, this firm has not filed any scheduled processes for any acidified food products manufactured. Furthermore, there is no documentation or evidence to show that the operating processes used in manufacturing these acidified foods were established by a competent Processing Authority. This would include the processing parameters used for the Simply Thick thickening gel.

Acidified foods are not thermally processed to an extent that is sufficient to destroy the vegetative cells of microorganisms of public health significance capable of growing in the food. Specifically, it was found the Simply Thick gel is being cold-filled as an acidified food. The target pH for this product is (redaction) pH.

There is no scientific documentation available excluding this product from receiving a thermal process. TPL had been following process parameters that were established and in place for the SimplyThick product prior to its acquisition of the business in July 2008. (AmeriQual purchased Thermo Pac from H. J. Heinz in 2008)

Failure to perform chemical testing where necessary to identify sanitation failures and possible food contamination.

Failure to maintain equipment and utensils in an acceptable condition through appropriate cleaning and sanitizing.

Process deviations are not evaluated by a competent processing authority in accordance with procedures recognized by competent processing authorities as being adequate to detect any potential hazard to public health.

Specifically, due to no scheduled processes being filed for any acidified foods, every batch of every acidified food manufactured by this firm would be considered a deviation. However, the firm continued to manufacture and ship finished product without an evaluation.

US Department of Defense Thermo Pac LLC Contracts

The Defense Logistics Agency awarded Thermo Pac LLC a firm fixed $23,473,590 price contract for various food items on February 20, 2009.

The Defense Logistics Agency awarded Thermo Pac LLC a maximum $22,735,230 firm-fixed-price contract for various food items on February 16, 2010.

The Defense Logistics Agency awarded Thermo Pac LLC a fixed-price with economic price adjustment, indefinite-quantity contract with a maximum $20,164,784 for food items on January 27, 2012.