Inspections, Compliance, Enforcement, and Criminal Investigations
Setton Pistachio of Terra Bella, Inc. 9/14/09
Department of Health and Human Services
|Public Health Service
Food and Drug Administration
September 14, 2009
Joshua J. Setton, President & CEO
Setton Pistachio of Terra Bella, Inc.
85 Austin Blvd.
Commack, NY 11725
Dear Mr. Setton:
The Food and Drug Administration (FDA) conducted an inspection of your nut processing facility located at 9370 Road 234, Terra Bella, CA, from March 26 through April 30, 2009. This inspection revealed that pistachios processed by your facility were adulterated within the meaning of section 402(a)(1) and (a)(4) of the Federal Food, Drug, and Cosmetic Act (the Act) [21 U.S.C. § 342(a)(1) and (a)(4)]. FDA notes that these pistachios were subsequently recalled by your firm. You can find the Act and its associated regulations on the internet through links on the FDA web page at www.fda.gov.
During the inspection, a sample of "ROASTED & SALTED GARLIC/ ONION" pistachios processed at your facility was collected and analyzed. FDA analysis of these pistachios revealed the product to be contaminated with Salmonella montevideo (S. montevideo). Salmonella, including the S. montevideo serotype, is a microorganism that is known to be pathogenic to humans. Foods containing Salmonella pose a danger to health and are adulterated within the meaning of Section 402(a)(1) of the Act, in that they contain a poisonous or deleterious substance which may render the product injurious to health.
In addition, FDA analyzed environmental samples collected from various locations within your firm's processing facility during the inspection. The analysis of these environmental samples found Salmonella in three separate processing areas. Each of these positive subsamples was further serotyped and determined to be S. montevideo, the same serotype with an indistinguishable Pulsed-Field Gel Electrophoresis (PFGE) pattern as isolated from the samples of finished product. The recovery of indistinguishable S. montevideo serotype patterns from multiple processing locations within your facility indicates that Salmonella may have become established in a niche environment in your facility. Further, finding Salmonella very near to where food is exposed indicates a high risk of product contamination. Based on our analytical and inspection findings, we determined that your firm's pistachio products were adulterated within the meaning of Section 402(a)(4) of the Act, in that they were prepared, packed, or held under insanitary conditions whereby they may have been contaminated with filth or may have been rendered injurious to health.
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.
Further, serious violations of the Current Good Manufacturing Practice (GMP) regulation fur foods, Title 21, Code of Federal Regulations (CFR), Part 110 (21 CFR 110), including violations that created possible routes of cross-contamination, were identified by our investigators and documented on the Form FDA- 483, Inspectional Observations, issued to your firm on April 30, 2009. We have reviewed your May 12, 2009, response to the Form FDA-483 and have determined that the significant GMP deviations appear to be adequately addressed. However, we are concerned about your recordkeeping practices because our inspection found that many of your records were either incomplete or missing. In your response, you state that you have reassessed your HACCP Plan, along with the associated prerequisite programs, and that you have identified enteric bacteria as a hazard. In addition, your response states you are implementing the revised HACCP Plan and associated procedures. A successful HACCP Plan and the associated standard operating procedures (SOPs) and sanitation standard operating procedures (SSOPs) require complete and accurate records to ensure that adequate monitoring, verifications, controls, and corrective actions are achieved. The adequacy of your corrective actions, along with the implementation of these corrections, will be verified during our next inspection.
This letter may not list all the violations at your facility. You are responsible for ensuring that your processing plant operates in compliance with the Act and the GMP regulation (21 CFR Part 110). Failure to implement lasting corrective action of these violations may result in regulatory action being initiated by FDA without further notice. For example, we may take further action to seize your products and/or enjoin your firm from operating.
We request that you notify this office in writing, within 15 working days from your receipt of this letter, of the current status of implementing your corrective actions since your May 2009 correspondence, including any further specific steps that you have taken to correct the noted violations. 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 violations.
Please send your reply to the Food and Drug Administration, Attention: Russell A. Campbell, Compliance Officer, 1431 Harbor Bay Parkway, Alameda, CA. If you have questions regarding any issue in this letter, please contact Russell Campbell at (510) 337-6861.
Barbara J. Cassens