The FDA has made the observations from its recent inspection of Sunland Inc. publicly available. The inspection was conducted between September 17 and October 16, 2012, and became part of the investigation of the Salmonella Bredeney outbreak linked to peanut butter made by Sunland Inc.
The CDC reported that a total of 41 persons infected with the outbreak strain of Salmonella Bredeney have been reported from 20 states. The number of ill persons identified in each state is as follows: Arizona (1), California (7), Connecticut (3), Illinois (1), Louisiana (1), Massachusetts (3), Maryland (1), Michigan (1), Minnesota (1), Missouri (2), Nevada (1), New Jersey (2), New Mexico (1), New York (2), North Carolina (2), Pennsylvania (2), Rhode Island (1), Texas (5), Virginia (2), and Washington (2).
During this inspection investigators found that conditions in the company’s facility, the company’s manufacturing processes, and the company’s testing program for Salmonella may have allowed peanut butter that contained Salmonella to be distributed by the company.
The FDA found that between June of 2009 and August of 2012, Sunland Inc. had distributed, or cleared for distribution, portions of 11 lots, or daily production runs, of peanut or almond butter after its own testing program identified the presence of at least one of nine different Salmonella types (Arapahoe, Bredeney, Cerro, Dallgow, Kubacha, Mbandaka, Meleagridis, Newport, and Teddington) in those lots. Two of these lots showed the presence of the outbreak strain of Salmonella Bredeney.
Equally important, five product samples collected and analyzed by FDA from Sunland Inc. showed the presence of Salmonella, but had not been identified as containing Salmonella by Sunland Inc.’s internal testing. Among those products were peanut butter and shelled raw peanuts. Two of these samples showed the presence of the outbreak strain of Salmonella Bredeney.
Additionally, during its inspection of the plant in September and October 2012, the FDA found the presence of Salmonella in 28 environmental samples. Three of these samples showed the presence of the outbreak strain of Salmonella Bredeney.
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.