FDA WARNING_LETTER - Sprouts Unlimited Inc - January 09, 2020

The FDA inspected a sprouting operation in Marion, Iowa, from December 31, 2019, to January 9, 2020, following an E. coli O103 outbreak linked to the firm's clover sprouts, which sickened 22 people. The FDA determined the clover sprouts were adulterated under 21 U.S.C. § 342(a)(1) due to the presence of a deleterious substance. Additionally, all sprout products were deemed adulterated under 21 U.S.C. § 342(a)(4) for being prepared, packed, or held under insanitary conditions, violating the Produce Safety Rule (21 CFR Part 112). Significant violations included: 1) Failure to test spent sprout irrigation water from each production batch for E. coli O157:H7 and Salmonella (21 CFR 112.144(b)). 2) Failure to hold products from entering commerce until receiving negative test results (21 CFR 112.147(b)). 3) Failure to implement adequate corrective actions after environmental samples tested positive for Listeria species or L. monocytogenes (21 CFR 112.146(a), (d), (e), (f)). 4) Failure to properly clean and sanitize food contact surfaces before use (21 CFR 112.143(b)). The firm's January 31, 2020, response was found inadequate due to a lack of supporting documentation for claimed corrective actions. The FDA requires a written response within fifteen working days detailing specific corrections and preventative measures, with supporting evidence, to avoid potential legal action like seizure or injunction.