FDA WARNING_LETTER - Holy Land Brand Inc. - March 09, 2018

On February 2, 2018, the FDA inspected Holy Land Brand, Inc.'s food storage warehouse in Minneapolis, Minnesota, revealing serious violations of 21 CFR Part 117 (CGMP & PC Rule). The inspection found significant rodent activity and insanitary conditions, including rodent excreta pellets, a rodent nest in rice, and a gnawed rice bag. FDA analysis confirmed the presence of rodents and excreta, leading to the determination that food products susceptible to rodent activity, like bagged rice and beans, are adulterated under 21 U.S.C. § 342(a)(4).

The primary violation cited was the failure to take effective measures to exclude pests and protect food from contamination, as required by 21 CFR 117.35(c). Specific observations included rodent nests, numerous rodent excreta pellets on walls, under racks, and on pallets of white beans, rice, and lentils, a gnawed hole in a rice bag, and live rodents in traps. Gaps under doors and around I-beams were identified as entry points for rodents.

While Holy Land Brand, Inc. disposed of some affected rice and submitted a response on March 23, 2018, outlining corrective actions, the FDA found the response inadequate. The firm claimed no rodent activity was reported by their pest control company, but FDA investigators found reports indicating activity and recommended corrections that were not addressed. Although