The FDA has Sprouts Unlimited Inc. on a short leash, according to a warning letter detailing how the Jimmy John’s supplier has consistently failed to respond to the contamination that eventually resulted in a 2019 outbreak.

If the company fails to correct pathogen problems in its sprout growing factory the federal government is ready to step in and shut it down, states a warning letter sent to company president William Beach. The Food and Drug Administration gives business owners 15 days from receipt of a warning letter to respond. The letter posted today is dated Feb. 21.

“Failure to promptly correct these violations may result in legal action by FDA without further notice, including seizure and/or injunction,” according to the warning letter signed by Cheryl A. Bigham, district director of FDA’s Kansas City District Office.

The warning letter says laboratory testing confirmed that the E. coli O103 strain that infected outbreak victims was present at the Sprouts Unlimited factory and in the finished product. On Dec. 27, 2019, the company initiated a limited recall of some of its clover sprouts that were distributed to Jimmy John’s restaurants and Hy Vee and Fareway grocery stores.

The FDA inspected the Sprouts Unlimited factory in Marion, IA, from Dec. 31, 2019, to Jan. 9, 2020. Traceback investigators found a link between outbreak victims and the Sprouts Unlimited produce, which triggered the inspection.

“FDA conducted this inspection because sprouts grown at your operation were linked by the state of Iowa Department of Inspections and Appeals, Department of Public Health, and the (FDA redacted) to an outbreak of human infections with Shiga toxin-producing E. coli O103 in the state of Iowa,” the warning letter states

The outbreak sickened 22 people between Nov. 21 and Dec. 14, 2019. The federal Centers for Disease Control and prevention did not post an outbreak notice on the situation because it only involved one state. The CDC generally is involved in only multi-state outbreak investigations, according to an agency spokesperson.

The FDA warning letter states that as of Jan. 7 the outbreak had sickened 22 people between Nov. 21 and Dec. 14, 2019. Testing showed clover sprouts were the main problem.

“. . . we have determined that your clover sprouts are adulterated within the meaning of (federal law) in that your clover sprouts bear or contain any added poisonous or deleterious substance which may render them injurious to health,” the FDA warning states.

“. . . FDA investigators documented numerous serious violations of the Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption . . . that may have resulted in the contamination of your sprouts with human pathogens.  

“Accordingly, your mung bean, red bean, alfalfa, clover, broccoli, onion, radish, pea, and lentil sprout products, and any combination thereof, are further adulterated within (federal law), in that they were prepared, packed, or held under insanitary conditions wherby they may have become contaminated with filth or been rendered injurious to health.”

Beach, the president of Sprouts Unlimited, responded to the FDA on Jan. 31 regarding several issues detailed in the warning letter. The agency deemed the responses inadequate.

Among the FDA’s points:

based on a traceback investigation conducted by the Iowa Department of Inspections and Appeals for this outbreak, ill persons reported the source or likely source of their sprout exposures as one of 15 sandwich restaurants that are a part of the same restaurant franchise.

On Dec. 23, 2019, the company collected 16 samples of clover sprouts and two spent irrigation water samples and 15 of the 16 sprout samples and one of the water samples yielded E. coli O103. Whole-genome sequencing (WGS) on the E. coli O103 obtained from the clover and water samples was compared with whole-genome sequencing results of isolates of E. coli O103 obtained from outbreak patient specimens. The comparison showed the E. coli likely came from the same source.

The company did not test spent sprout irrigation water (SSIW) from each production batch of sprouts for E. coli O157: H7 and Salmonella, as required by federal law. 

The company did not take steps to hold all products from entering commerce before receiving results from the spent sprout irrigation water tests, as required by (federal law).

The company did not take corrective actions, as required by federal law, when environmental samples of growing, harvesting, packing, or holding areas tested positive for Listeria species or Listeria monocytogenes.

The company moved racks of sprouts around in the factory without keeping track of lot numbers or testing records, making traceability virtually impossible.

The company failed to conduct appropriate testing following the detection of Listeria.

The company did not clean and sanitize food contact surfaces used to grow, harvest, pack, or hold sprouts before contact with sprouts or seeds or beans used to grow sprouts, as required by (federal law). Specifically, on Dec. 26, 2019, it was notified by a contract laboratory that clover sprout samples and SSIW samples collected, and submitted for analysis on Dec. 23, 2019, confirmed the presence of E. coli O103 in both your clover sprouts and SSIW. Following this notification, you did not clean trays used for sprouting seeds prior to exposing the trays. FDA investigators observed that the trays used for growing sprouts were not cleaned. It is common for the residue to build up on sprout growing equipment if appropriate cleaning and sanitizing procedures are not followed, which could allow for biofilm formation.  

Editor’s note: William Beach, president of Sprouts Unlimited Inc., is not related to Coral Beach, editor of Food Safety News.