Inspections, Compliance, Enforcement, and Criminal Investigations
Valley Harvest Nut Company 11/6/09
Department of Health and Human Services
|Public Health Service
Food and Drug Administration
|San Francisco District
1431 Harbor Bay Parkway
Alameda, CA 94502-7070
November 6, 2009
Bobby E. Conway, President
Valley Harvest Nut Company, Inc.
3242 S. Carpenter Road
Modesto, CA 95358
Dear Mr. Conway:
On July 14 - 31, 2009, investigators from the U.S. Food and Drug Administration (FDA) conducted an inspection of your almond processing facility located at 3242 S. Carpenter Road, Modesto, CA 95358. The inspection revealed that almonds processed by your facility have been prepared, packed, or held under insanitary conditions whereby the almonds may have been rendered injurious to health. Therefore, the almonds were 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)].
During the inspection, environmental samples were collected from various locations within your processing facility and analyzed. The analysis revealed the presence of Salmonella senftenberg (S. senftenberg) in fourteen (14) subsamples. Specifically, Pulsed Field Gel Electrophoresis (PFGE) testing determined that six (6) separate PFGE patterns of S. senftenberg were present in your facility and that four (4) of these patterns were present in multiple locations within your facility. The recovery of the four S. senftenberg serotypes from multiple locations within your facility is a significant concern because it indicates that the pathogen is a potential resident organism in your facility. Further, finding Salmonella very near to where food is exposed indicates a high risk of product contamination.
During your discussion with FDA investigators, you stated that you performed a targeted cleaning of the areas where FDA found positive samples, and then collected environmental samples from those locations. However, that testing revealed some positive samples. In addition, you stated that you send out finished product samples every other week for various tests, including Salmonella. These procedures may not be sufficient to identify all of the areas of the facility in which this organism is able to grow (niche areas). It is essential that you identify the niche areas and to take such corrective actions as are necessary to eradicate the organism by rendering these areas unable to support the growth and survival of the organism.
FDA's inspection also revealed serious violations of the Current Good Manufacturing Practice (CGMP) regulation for foods, Title 21, Code of Federal Regulations, Part 110 (21 CFR 110). Failure to adhere to the requirements of 21 CFR 110 also renders your firm's almonds adulterated within the meaning of Section 402(a)(4) of the Act in that they have been prepared, packed, or held under insanitary conditions whereby they may have become contaminated with filth, or whereby they may have been rendered injurious to health. You may find the Act and the CGMP regulation for foods through links in FDA's home page at www.fda.gov.
At the conclusion of the inspection, you were issued a Form FDA-483, Inspectional Observations, which documented insanitary conditions and CGMP deviations present in your facility at the time of the inspection. The insanitary conditions and CGMP deviations included the following:
1. You must ensure that equipment, containers, and utensils used to convey, hold, or store raw materials, work-in-process, rework, or food are constructed, handled, and maintained during manufacturing or storage in a manner that protects against contamination. 21 CFR 110.80(b)(7). However, you failed to handle and maintain containers and equipment that hold or convey food in a manner that protects against contamination, as evidenced by:
• Bins, which had been stored directly on the floor, were placed on top of other bins containing almonds which have been roasted, sliced, diced or mixed into butter, without any physical barrier to prevent contamination.
• You were using dirty and hard to clean materials to modify and/or repair equipment, containers, and utensils. Specifically, cardboard was used to enclose the conveyor on the roaster and to enclose the funnel on the dicer machine. Duct tape was used to attach the cardboard enclosures, reinforce utensil handles, and on the sides of the bins used to hold almonds.
• Forklifts traveled directly from outside the facility into the almond production and storage areas without any cleaning or sanitization.
2. You must take effective measures, including adequate screening or other protections, to exclude pests from the processing areas and to protect against the contamination of food on the premises by pests. 21 CFR 110.20(b)(7) and 110.35(c). However, you failed to exclude pests from your processing areas and food storage areas as evidenced by the following:
• There was a hole in the processing room wall adjacent to the almond slicer. The hole opened directly to the outside without any screening or enclosure to prevent pest entry.
• Numerous flies were seen landing directly on food product and food contact surfaces.
• Rodent excreta droppings were observed in the room where finished product was being stored.
We have received your written response, dated August 5, 2009, to the Form FDA-483, in which you state you have corrected or promise to correct the deficiencies listed. However, your response fails to adequately address the violative conditions listed above as follows:
You state in your response that you have initiated the use of cardboard barriers between bins when stacked on top of each other. You also state that you already use a sealed poly liner in the bins. However, our inspection found that there were no poly liners in the slider bins. In addition, your response fails to provide sufficient information regarding the controls implemented for the use of the cardboard barriers, such as whether they are single or multiple use, how unused cardboard barriers are stored, and the procedures established to ensure that the side of the barrier exposed to the bottom of a bin is not subsequently exposed to food product.
The controls you have instituted to control pests do not provide sufficient assurance to protect food products from contamination. Your response states that the hole in the wall has been repaired, additional fly traps will be placed near doors, and that steps have been taken to screen the door in the sizer room, However, you did not provide sufficient details to ensure that flies will be excluded from the processing area, and you completely failed to address the control of rodents.
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 applicable statutes enforced by the FDA. You should take prompt action to correct all of the violations noted in this letter. Failure to promptly correct these violations may result in regulatory action without further notice, such as seizure and/or injunction.
Please respond in writing within fifteen working days from your receipt of this letter. Your response should outline the specific things you are doing to correct these deviations. If you cannot complete all corrections before you respond, we expect that you will 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: Russell A. Campbell, Compliance Officer, 1431 Harbor Bay Parkway, Alameda, CA 94501. If you have questions regarding any issue in this letter, please contact Russell A. Campbell at (510) 337-6861.
Barbara J. Cassens
San Francisco District
U.S. Food and Drug Administration