FDA WARNING_LETTER - Chicago Indoor Garden, Inc. - March 31, 2020

The FDA inspected a sprouting operation at 4459 W. Division St., Chicago, IL, from February 28 to March 31, 2020, due to its link to an E. coli O103 outbreak. FDA analysis confirmed E. coli O103 in red clover sprouts, rendering them adulterated under 21 U.S.C. §342(a)(1).

The inspection also revealed serious violations of the Produce Safety regulation (21 CFR Part 112), leading to adulteration under 21 U.S.C. § 342(a)(4) due to insanitary conditions. Specifically, the operation failed to discontinue using a clover seed lot (b)(4) after being notified by the supplier of a recall by another operation and potential contamination, resuming use in January 2020 after a December 2019 hold, violating 21 CFR 112.142(b)(1). Additionally, food contact surfaces of sprout drums had yellowish-brown and black residues, indicating inadequate cleaning and maintenance, violating 21 CFR 112.123(d)(1).

The company's April 15, 2020, response to the FDA-483, including a recall of red clover sprouts and cessation of production, was acknowledged but deemed insufficient for evaluation. Corrective