FDA released the findings from the Sunland Food investigation. This investigation was conducted after Trader Joe's peanut butter, which was made by Sunland, was linked to 41 cases of Salmonella in 20 states.
The findings are very troubling. (Each numbered bullet point references a spot in the report).
http://www.fda.gov/food/foodsafety/corenetwork/ucm320413.htm
The FDA has made the observations from its recent inspection of Sunland Inc.1 publicly available. This 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.
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.
[1] 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.
[2] 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.
[3] 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.
Upon identifying the contaminated peanut butter, FDA investigators informed the company and called for corrective action. On October 4, 2012 Sunland Inc. expanded its ongoing recall to include all products made in the Sunland Inc. nut butter production facility between March 1, 2010 and September 24, 2012.
[4] Upon identifying the contaminated shelled raw peanuts, FDA investigators informed the company and again called for corrective action. On October 12, 2012 Sunland Inc. expanded its ongoing recall to include raw and roasted shelled and in-shell peanuts sold in quantities from 2 ounces to 50 pounds which are within their current shelf life or have no stated expiration date.
[5] 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.
[6] There were no records documenting the cleaning of production equipment. [7] The super-sized bags used by the firm to store peanuts were not cleaned despite being used for both raw and roasted peanuts. [8]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.
[9]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.
The FDA is currently evaluating Sunland Inc.'s official response to FDA's observations from the inspection.
Collaborative investigation efforts of state, local, and federal public health and regulatory agencies indicate that Trader Joe's Valencia Creamy Salted Peanut Butter made with Sea Salt, manufactured by Sunland, Inc. of Portales, New Mexico, is a likely source of this outbreak.
CDC recommends that consumers do not eat recalled peanut butter or other recalled products containing nuts and seeds and dispose of any remaining jars of product in the home or return the product to the place of purchase.
The numbers of new cases have declined substantially, but because these products have a long shelf-life, the outbreak could continue at a low level for the next several months if consumers are unaware that they still have recalled products in their home and continue to consume them.
The findings are very troubling. (Each numbered bullet point references a spot in the report).
- Company shipped product after their own testing found it to contain Salmonella. Occurance in 11 lots.
- Five lots tested and found to be negative by company were actually positive when tested by FDA.
- 28 environmental samples were found to be positive for Salmonella.
- The FDA tested and found shelled peanuts contaminated which resulted in Sunland expanding the recall to that product line.
- Poor employee practice including the lack of hand washing.
- No records for the documentation of cleaning processing equipment.
- Reuse of sacks for both raw and finished product without cleaning.
- Poor plant drainage systems that prohibited good cleaning.
- Storage of raw peanuts allowed for cross contamination (birds were flying into the uncovered trailers. Storage conditions also allowed for moisture and pest entry).
FDA Investigates Multistate Outbreak of Salmonella Bredeney Infections Linked to Peanut Butter made by Sunland Inc.
Posted November 21, 2012http://www.fda.gov/food/foodsafety/corenetwork/ucm320413.htm
Updates
November 14, 2012 - FDA posts observations from recent inspection at Sunland Inc.The FDA has made the observations from its recent inspection of Sunland Inc.1 publicly available. This 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.
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.
[1] 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.
[2] 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.
[3] 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.
Upon identifying the contaminated peanut butter, FDA investigators informed the company and called for corrective action. On October 4, 2012 Sunland Inc. expanded its ongoing recall to include all products made in the Sunland Inc. nut butter production facility between March 1, 2010 and September 24, 2012.
[4] Upon identifying the contaminated shelled raw peanuts, FDA investigators informed the company and again called for corrective action. On October 12, 2012 Sunland Inc. expanded its ongoing recall to include raw and roasted shelled and in-shell peanuts sold in quantities from 2 ounces to 50 pounds which are within their current shelf life or have no stated expiration date.
[5] 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.
[6] There were no records documenting the cleaning of production equipment. [7] The super-sized bags used by the firm to store peanuts were not cleaned despite being used for both raw and roasted peanuts. [8]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.
[9]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.
The FDA is currently evaluating Sunland Inc.'s official response to FDA's observations from the inspection.
CDC Release
Multistate Outbreak of Salmonella Bredeney Infections Linked to Peanut Butter Manufactured By Sunland, Inc.
Posted November 8, 2012 4:15 PM ET
Highlights
- Read the Advice to Consumers »
- A total of 41 persons infected with the outbreak strain of Salmonella Bredeney have been reported from 20 states.
- 28% of ill persons have been hospitalized, and no deaths have been reported.
- 63% percent of ill persons are children under the age of 10 years.
- This is especially important for children under the age of 5 years, older adults, and people with weak immune systems because these people are at a higher risk for serious illness.
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