The FDA flexed its muscles on Monday, suspending the food-facility registration of Sunland Inc., the company that manufactured peanut butter linked to an outbreak of salmonella that has sickened 41 people in twenty states. The suspension effectively prevents Sunland from producing any food products until further notice.
This is the first time that the FDA has employed its authority, granted in 2011, to suspend a company's food facility registration.
In a statement posted on its website today, Sunland expressed "surprise" at the FDA's action:
Sunland had hoped to recommence its shelling operation on November 26, 2012 and informed the FDA of the plan in a letter dated November 20, 2012. Sunland expected that any agency concerns with its plans would be part of the ongoing dialogue with the agency. The agency's order suspending Sunland's registration on November 26, 2012 was unexpected and the company is disappointed by this development. Sunland's goal remains the same--to take all appropriate measures for the safe processing and handling of raw peanuts in its shelling plant and the safe production of nut butter products in its peanut butter plant. Sunland is continuing to work with FDA in order to accomplish all steps necessary to begin shelling operations in its peanut mill as soon as possible.
In addition to the salmonella contamination, FDA reports finding numerous unsanitary conditions at Sunland Inc. over recent years:
Additionally, investigators found that employees improperly handled equipment, containers, and utensils used to hold and store food. Employees handling peanut products wiped gloved hands on street clothes and other times failed to wash their hands or change gloves. There were no hand washing sinks in the peanut processing building production or packaging areas and employees had bare-handed contact with ready-to-package peanuts.
There were no records documenting the cleaning of production equipment. The super-sized bags used by the firm to store peanuts were not cleaned despite being used for both raw and roasted peanuts. There was a leaking sink in a washroom which resulted in water accumulating on the floor, and the plant is not built to allow floors, walls and ceilings to be adequately cleaned.
Finally, investigators found that raw materials were exposed to potential contamination. Raw, in-shell peanuts were found outside the plant in uncovered trailers. Birds were observed landing in the trailers and the peanuts were exposed to rain, which provides a growth environment for Salmonella and other bacteria. Inside the warehouse, facility doors were open to the outside, which could allow pests to enter.