Inspections, Compliance, Enforcement, and Criminal Investigations
Willamette Shelling Inc 5/10/10
Department of Health and Human Services
|Public Health Service
Food and Drug Administration
22201 23rd Drive SE
Bothell, WA 98021-4421
May 10, 2010
RETURN RECEIPT REQUESTED
In reply refer to Warning Letter SEA 10-20
Benson C. Mitchell, President
Willamette Shelling, Inc.
14975 North East Tangen Road
Newberg, Oregon 97132
Dear Mr. Mitchell:
On November 17-20, 2009, the U.S. Food and Drug Administration (FDA) conducted an inspection of your hazelnut processing facility located at 14975 North East Tangen Road, Newberg, Oregon and collected environmental samples from various locations within your facility. FDA conducted a follow-up inspection of your facility on November 30, 2009 to December 9, 2009. FDA laboratory analyses of the environmental samples collected during our first inspection found the presence of Salmonella. In addition, we found that you have significant deviations from the Current Good Manufacturing Practice (CGMP) regulation for foods, Title 21, Code of Federal Regulations, Part 110 (21 CFR 110).
These violations and the results of the laboratory analyses cause the foods manufactured at your facility to be adulterated within the meaning of Section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act (the Act) [21 U.S.C. § 342(a)(4)], in that they were prepared, packed, or held under insanitary conditions whereby they may have become contaminated with filth or rendered injurious to health. You can find links to the Act and FDA's regulations through links on FDA's website at www.fda.gov.
During the inspection, our investigators collected several environmental samples from various surfaces throughout your facility. Six of these samples tested positive for Salmonella species. Two of these positive environmental samples were collected from food contact surfaces. In addition, two other positive environmental samples were collected near exposed food or food contact surfaces. Finding Salmonella on or near food contact surfaces and very near to where food is exposed indicates a high risk for product contamination.
The remaining two positive samples were collected from the floor of your facility and a step ladder located in the upstairs room with the grading drum. Bacteria may enter and/or be transported through a food plant by a variety of routes that include, but are not limited to: the shoes of employees, contractors, and visitors; the wheels of fork lifts, pallet movers, and moveable equipment; soiled pallets; soiled raw material packing; on raw ingredients, particularly tree nuts; roof leaks; and by rodent vectors. Once established on product area floors, the organism can contaminate food and food-contact surfaces through either human or mechanical means.
Appropriate control of Salmonella in a food processing environment requires expert knowledge of the unique characteristics of the organism. It is essential to identify the areas of the food processing plant where this organism is able to grow and survive (niche areas) and to take such corrective actions as necessary to eradicate the organism by rendering these areas unable to support the growth and survival of the organism.
We acknowledge that on December 17, 2009 your firm initiated a recall of all shelled hazelnuts processed in your facility from October 12, 2009 to November 25, 2009. We also received your firm's response letter dated November 23, 2009. During FDA's inspection on November 17-20, 2009, investigators documented numerous CGMP violations (21 CFR 110), including evidence of rodent and insect activity in your dry storage warehouse. Your response letter appears to address these observations, but the effectiveness of your corrections 'will be verified during a subsequent inspection. Our other comments to your response letter are included below.
1. To comply with section 21 CFR 110.80, you must ensure that all operations in the receiving, transporting, segregating, preparing, manufacturing, packaging, and storage of food are conducted in accordance with adequate sanitation principles. However, our investigators observed that the plastic curtains between the in-shell and kernel warehouses had residual organic matter on its surfaces. Further, our investigators observed that hazelnut kernels in a metal tote came in contact with the plastic curtains while the kernels were being transported into the kernel warehouse. Our investigators collected environmental sample 519326, subsample number 149, from the bottom of the plastic curtains. The sample tested positive for Salmonella typhimurium.
In December 2009, the Oregon Department of Agriculture (ODA) sampled and analyzed your hazelnut kernels and found the presence of Salmonella. FDA conducted a pulse field gel electrophoresis (PFGE) analysis by two enzymes on one of the ODA Salmonella isolates from your hazelnut kernels. FDA determined the ODA isolate had a PFGE pattern that was indistinguishable from the Salmonella typhimurium collected and isolated from the plastic curtain. This finding is significant because it indicates that the Salmonella may have transferred from the plastic curtains to the hazelnuts kernels.
A second food contact surface tested positive for Salmonella.Environmental sample 519325, subsample number 19, was collected from the face of a scraper/rake, which your firm uses to move or rake hazelnuts in the upstairs room with the grading drum.
Additionally, two environmental subsamples testing positive for Salmonella typhimurium were collected near exposed food or food contact surfaces: environmental sample 519326, subsample number 118, was collected from the power cable for the line (b)(4) elevator in the sorting room, which was above and in close proximity to an uncovered metal tote containing hazelnut kernels; and environmental sample 519326, subsample number 169, was collected from the plastic covering of a grading drum in the in-shell warehouse. These two environmental subsamples were indistinguishable from a second ODA isolate collected from your finished hazelnut product, as determined by PFGE analysis. This finding is significant because it indicates that Salmonella may have been transported throughout your facility and may have established niche areas to colonize.
We acknowledge that your firm informed our investigators that it had removed the plastic curtains, discussed above, and that your firm was cleaning your facility. Your firm should identify areas where Salmonella can grow and survive, and develop and implement a cleaning and sanitation program to eradicate the organism by rendering these areas unable to support the growth and survival of the organism. The effectiveness of your corrections will be verified during a subsequent inspection.
2. To comply with section 21 CFR 110.80(b)(2), you must ensure that all food manufacturing, including packaging and storage, be conducted under such conditions and controls as are necessary to minimize the potential for the growth of microorganisms, or for the contamination of food.
Environmental sample 519325, subsample number 20, was collected from the floor near the top step of the stairs leading to your upstairs room with the grading drum. Environmental sample 519325, subsample number 6, was collected from the second rung from the top of a step ladder located in the same room. Both of these environmental subsamples, collected from surfaces which can come into contact with employees' shoes, tested positive for Salmonella. Employees may potentially transmit Salmonella through their shoes.
Our investigators observed one employee stepping on a black plastic stool by the spout of a metal tote when taking samples for grading, and while flattening out heaps of hazelnut kernels. The hazelnut kernels exit from this spout when an individual empties the metal tote, such as during packaging. The employee's shoes were near and above the spout. This practice does not minimize the potential for contamination of your hazelnut kernels.
As noted above, ODA sampled and analyzed your hazelnut kernels for the presence of Salmonella FDA conducted a PFGE analysis by two enzymes on another ODA Salmonella isolate from your hazelnuts. FDA determined that the ODA isolate was indistinguishable from the Salmonella typhimurium collected and isolated from the rung from the top of the step ladder located in the upstairs room with the grading drum. This finding is significant because the environmental sample was taken from a step ladder and the indistinguishable PFGE pattern was found in your firm's finished hazelnut product. This finding indicates that Salmonella may have been transported throughout your facility and may have established niche areas to colonize.
Our investigators also observed cobwebs and dirt on the underside of the metal totes, and that the totes were stacked above other uncovered metal totes of hazelnut kernels in the in-shell warehouse. The bottom of your firm's totes can and do come into contact with the floor. Storing totes, which may be contaminated by dirt, debris, or pathogens, by stacking the totes above uncovered totes containing exposed product does not minimize the potential for contamination.
We acknowledge that your response letter states that your firm has instructed employees not to use the plastic stool in the tote spout area, and that all metal totes will be covered. Your response letter also states that your firm's previous practice was to clean the totes before each season, but that you will now clean the totes on an as needed basis. All food-contact surfaces are required to be cleaned as frequently as necessary to protect against contamination of food under 21 CFR 110.35(d). The effectiveness of your corrections will be verified during a subsequent inspection.
The above violations are not meant to be an all-inclusive list of deficiencies in your facility. It is your responsibility to ensure that all of your products are in compliance with the Act and FDA regulations. You should take prompt action to ensure that your finished product hazelnuts are not manufactured under conditions which may cause them to be contaminated with pathogenic organisms. Failure to promptly correct violations of the Act may result in regulatory action without further notice, such as seizure and/or injunction.
Please respond in writing within fifteen (15) days from your receipt of this letter. Your response should include each step that has been taken to completely correct the current violations and to prevent the recurrence of similar violations, the timeframe within which each correction will be completed, and any documentation necessary to show that correction has been achieved. If you cannot complete all corrections before you respond, please explain the reason for your delay and state when you will correct any remaining deviations.
Please send your reply to the Food and Drug Administration, Attention: Scott A. Nabe, Compliance Officer, 22201 23rd Drive SE, Bothell, Washington 98021-4421. If you have questions regarding any issue in this letter, please contact Scott A. Nabe, Compliance Officer at
Charles M. Breen
cc: ODA with disclosure statement
Benson C. Mitchell
Willamette Filbert Growers, Inc.
14875 NE Tangen Road
Newberg, Oregon 97132