“Since 2009, your firm has distributed lots of peanut butter and nut butters that were positive for Salmonella. The following is a list of products since 2009 that have been manufactured by your firm, have tested positive for Salmonella by your firm’s internal testing program, and were at least partially distributed by your firm.”
- FDA Form 483, issued October 29, 2012
It’s Peanut Corporation of America all over again.
Earlier today, FDA released a series of Enterprise Inspection Reports and Form 483 reports issued following inspections of Sunland Inc.‘s production facilities in Portales, New Mexico from as long ago as 2007.
The company, whose peanut butter was definitively linked to an outbreak of Salmonella Bredeney that sickened at least 41 people from 20 states, has known about its Salmonella contamination problems since at least June 2009. Somehow, this information escaped the notice of the company’s customers – including Trader Joe’s – its third party auditors, and FDA inspectors for more than 2 years.
According to company records reviewed by FDA, Sunland found Salmonella contamination in its nut butters (peanut and almond) on more than 20 occasions, including findings of Salmonella Newport in 2009, Salmonella Dallgow in 2010, Salmonella Dallgow, Salmonella Arapahoe, Salmonella Teddington, Salmonella Cerro, Salmonella Mbandaka and Salmonella Kubacha in 2011, and Salmonella Bredeney and Salmonella Meleagridis in 2012.
FDA’s own in-depth inspection – carried out in September and October 2012 after epidemiologists pointed to Sunland’s peanut butter as the likely source of an outbreak of Salmonella Bredeney – found Salmonella Bredeney in samples of peanut butter, as well as Salmonella Senftenberg, Salmonella Montevideo, Salmonella Bredeney, Salmonella Mbandaka, Salmonella Meleagridis, and Salmonella Anatum in the production plant environment.
That’s more strains of Salmonella than many labs maintain in their reference collection!
In addition to turning a blind eye to the contamination that pervaded its operations since 2009, Sunland’s management ignored standard Good Manufacturing Practices, as evidenced by the following litany of “Observations” reported by FDA in October 2012:
Observation 1: Failure to manufacture foods under conditions and controls necessary to minimize the potential for growth of microorganisms and contamination.
Observation 2: Failure to handle equipment, containers and utensils used to convey, hold, and store food in a manner that protects against contamination.
- Specifically, the production and packaging lines of equipment in the Peanut Butter Plant were not cleaned after each time Salmonella was isolated from peanut and nut butter products between 2009 and 2012.
- The … packaging equipment in the small packaging room of the Peanut Plant is not effectively cleaned between raw and roasted peanuts. Cleaning consists of wiping off non-food contact surfaces with dry paper towels, sweeping underneath and around equipment, as well as vacuuming excess dust.
- Tote mesh bags utilized by your firm for storing bulk peanuts are not effectively cleaned between storage o f raw and treated (roasted and/or brined) peanuts. The tote bags are considered multi-use, and re-used for both raw and roasted peanuts.
- Firm does not clean production and packaging equipment between runs of various allergen-containing products.
Observation 3: Food contact surfaces used for manufacturing low-moisture food were wet at time of use.
Observation 4: The design and workmanship of equipment does not allow proper cleaning.
Observation 5: Failure to have smoothly bonded or well maintained seams on food contact surfaces, to minimize accumulation of food particles, dirt, and organic matter and the opportunity for growth of microorganisms.
Observation 6: Employees did not wash hands thoroughly in an adequate hand-washing facility at any time their hands may have become soiled or contaminated.
Observation 7: Plumbing is not adequately installed and maintained to properly convey sewage and liquid disposable waste from the plant.
Observation 8: The plant is not constructed in such a manner as to allow floors, walls, and ceilings to be adequately cleaned and kept clean and kept in good repair.
Observation 9: Failure to store raw materials in a manner that protects against contamination.
- From 9/17112-10/2112, raw, in-shell peanuts were observed outside in uncovered trailers and open to the elements. Birds too numerous to count were observed flying over, and landing on peanuts in the trailers.
- On 9/28/12, [FDA inspectors] observed the weather as overcast and rainy, seven open trailers filled with peanuts were observed stored uncovered on the front of [the] property exposed to moisture from the weather.
Observation 10: Effective measures are not being taken to exclude pests from the processing areas.
As for the company’s compliance history, consider the following:
In 2003, FDA cited the following problems: (1) the firm’s plumbing constitutes a source of contamination to food; (2) effective measures were not being taken to protect against the contamination of food on the premises by pests; (3) the firm failed to provide adequate screening or other protection against pests; (4) the firm failed to hold rework materials in bulk or in suitable containers so as to protect against contamination; and (5) the firm failed to maintain the buildings in repair sufficient to prevent food from becoming adulterated.
In 2007, FDA cited the following problems: (1) the firm failed to manufacture foods under conditions and controls necessary to minimize the potential for growth of microorganisms and contamination; (2) the firm failed to take reasonable precautions to ensure that production procedures do not contribute contamination from any source; (3) employees were observed not washing and sanitizing hands thoroughly in an adequate hand washing facility before starting work and after each absence from the work station; (4) effective measures were not being taken by the firm to protect against the contamination of food on the premises by pest (a repeat observation); (5) the firm failed to store raw materials in a manner that protects against contamination; and (6) the firm failed to maintain buildings in repair sufficient to prevent food from becoming adulterated (a repeat observation).
In 2009, FDA cited the following problems: (1) the firm failed to manufacture foods under conditions and controls necessary to minimize the potential of microorganisms and contamination (a repeat observation); (2) the firm failed to take all reasonable precautions to ensure that production procedures did not contribute contamination from any source (a repeat observation); (3) failure to take all reasonable measures and precautions to ensure personnel cleanliness by utilizing effective hair restraints and ensuring that beard covers were worn in an effective manner; (4) failure to ensure employees washed/sanitized their hands properly when returning from the work station (a repeat observation); (5) failure to maintain equipment used to hold food ingredients in a manner that protects them from contamination. Also, FDA found Salmonella in an environmental sample taken during its 2009 inspection.
In 2010, FDA cited the following problems: (1) All reasonable precautions are not taken to ensure that production · procedures do not contribute contamination from any source; (2) Effective measures are not being taken to exclude pests from the processing areas and protect against the contamination of food on the premises by pests; (3) The plant is not constructed in such a manner as to allow floors to be kept in good repair; (4) Failure to wear beard covers in an effective manner; (5) The design and construction of equipment and utensils fails to preclude the adulteration of food with contaminants.
In 2011, FDA cited the following problems: (1) Failure to store raw materials in a manner that protects against contamination; (2) Failure to provide adequate screening or other protection against pests.
Am I the only one who doesn’t understand what’s going on here?
Where were the company’s customers? Did they never visit the production plant?
Where was Silliker Laboratories, the company’s third party auditor? Did they ever visit the production plant or review the company’s internal lab results?
AND WHERE THE HELL WAS FDA? Why did the agency not review Sunland’s internal lab results and production/distribution records until after the company’s negligence resulted in a food poisoning outbreak?
If this is an example of “Food Safety Modernization” in action, please give me the Good Old Days.