FDA WARNING_LETTER - Green Explosion, Inc. - May 21, 2020

The FDA inspected the facility at 6960 NW 25 Street, Miami, Florida, on May 19 and 21, 2020, following a State's laboratory analysis of "Wild Harvest" brand organic basil that revealed the presence of *Cyclospora cayetanensis*. This human parasite indicates direct or indirect contamination with human feces. Consequently, the basil was deemed adulterated under section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act (the Act) [21 U.S.C. § 342(a)(4)] due to insanitary conditions, filth contamination, and potential health injury. The introduction of such an adulterated product into interstate commerce is a prohibited act under Section 301(a) of the Act [21 U.S.C. § 331(a)]. The firm voluntarily recalled lot (b)(4) of the basil on May 7, 2020. The FDA requires prompt corrective action to address these violations and prevent recurrence. The firm must respond in writing within fifteen working days, detailing specific steps taken, including documentation. Failure to comply may lead to legal action, including seizure and injunction, and the FDA may assess re-inspection fees. A virtual meeting is tentatively scheduled for September 22, 2020, to discuss the contamination and the firm's response.