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MAPLE ISLAND INFANT FORMULA PROCESSING FACILITY SHUT DOWN BY FDA CONSENT DECREE

This article was originally published in The Tan Sheet

Executive Summary

MAPLE ISLAND INFANT FORMULA PROCESSING FACILITY SHUT DOWN BY FDA CONSENT DECREE signed on Aug. 20 in Minneapolis federal court. The consent decree states that Stillwater, Minn.-based Maple Island is "permanently restrained and enjoined" from the "manufacturing, processing, preparing, packaging, or holding for sale of any food, including, but not limited to, infant formula." The consent agreement follows an FDA lawsuit seeking a permanent injunction against the company filed on Aug. 17. A Salmonella contamination at Maple Island's drying, canning and processing plant in Wanamingo, Minn. resulted in a number of Class I and Class II recalls beginning in March and running through July. Prior to the injunction, Maple Island had processed powdered products for 11 companies including Mt. Vernon-based Nutricia, manufacturer of Soyalac Infant Formula powder, which recalled 116 cases of Soyalac powder in March and issued a second recall in June. Nutricia said it has ceased production of all Soyalac Infant Formula powder products and is presently looking for a manufacturer. The Maple Island bacterial contamination also affected powdered nutritional products manufactured for Wyeth-Ayerst, Ross Labs and Dean Distributors. Wyeth-Ayerst has issued recalls for Enercal and Promil powdered nutritional supplements for infants and children while Ross Labs issued a Class I recall for Formance fortified powder, which is used by pregnant and lactating women. Dean Distributors, which markets a line of low-calorie meal replacement drinks, has recalled lots of its Medibase, Medibase II and Cambridge products that were processed by Maple Island. The consent decree formalizes FDA's June 29 request that all products dried or packaged at Maple Island's Wanamingo facility since November 1992 be recalled ("The Tan Sheet" Aug. 9, p. 15). The consent decree requires the recall of all products "manufactured, processed, prepared, packaged, or held in the facility, from Nov. 4, 1992, to the present." To resume regular manufacturing operations, the injunction states that Maple Island must comply with "the sanitation and quality control requirements set forth" by the decree. According to the injunction, Maple Island must "establish and implement methods, facilities and controls" that will ensure no future contamination by Salmonella bacteria or filth will occur. The decree also requires the company to: clean and renovate the facility and equipment in the plant; establish a written sanitation control program for the facility and all food handling equipment; assign a person with sanitation background and experience to direct the program; and establish written procedures that will record "the microbiological quality and purity of raw materials used in infant formula" and ensure that all complaints concerning infant formula are maintained and reported to FDA. In addition to these sanitary requirements, the injunction instructs Maple Island to appoint an independent consultant to inspect the food processing and storage facilities as well as the "facility and all equipment used therein." The consultant also is expected to oversee the establishment of an "adequate quality control program" and ensure that the necessary sanitary regulations have been implemented. After all requirements have been met, the injunction requires Maple Island to report to FDA in writing so that an "authorized FDA representative" can reinspect the facilities and machinery and determine that all sanitary requirements and good manufacturing practices requirements have been met. Maple Island will bear the cost of all FDA "inspections, supervisions, analyses and examinations at the facility." FDA will then notify Maple Island whether it is in compliance, according to the injunction. The injunction indicated that FDA's field staff will continue to inspect the plant "to ensure continuing compliance with the terms" of the decree. If, at any time, FDA determines that Maple Island is no longer in compliance, the injunction states, the company must cease manufacturing and "conduct any recalls FDA deems necessary."
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