FDA WARNING_LETTER - Global Protein Foods, Inc. - November 03, 2010

The FDA inspected Global Protein Foods, Inc. in Newark, New Jersey, from October 13 to November 3, 2010. The inspection found that soybean sprouts, soy beverages, tofu, and yuba were adulterated under 21 U.S.C. 342(a)(4) due to insanitary conditions, potentially leading to contamination.

Significant violations of 21 CFR Part 110 (CGMP) were identified. Insanitary conditions included finished soybean sprouts stored in soiled containers, an employee standing in the sprout hopper with unsanitized boots, dripping condensate onto production equipment and seeds, soiled employee uniforms, inadequate handwashing, clogged floor drains with pooling water, improper cleaning of sprout pans, and rust/filth-stained fabric bags used for sprout production water.

CGMP violations included lack of sanitizer in cleaning operations (21 CFR 110.80(b)(1)), poorly maintained equipment like stained conveyor belts and caked-on fryers (21 CFR 110.40(a)), and extensive pest infestations (dead mouse, flies, roaches, rodent excreta, spider webs) throughout the facility (21 CFR 110.35(c)). The firm also failed to provide adequate pest screening (21 CFR 110.20(b)(7)), had inadequate plumbing causing pooling water and no backflow prevention (21