ARO Pistachios, Inc. 1/13/14
| || |
Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
| ||San Francisco District|
1431 Harbor Bay Parkway
Alameda, CA 94501-7070
Telephone: (510) 337-6700
United Parcel Service
Delivery Signature Required
January 13, 2014
Adam R. Orandi, President
ARO Pistachios, Inc.
19570 Avenue 88
Terra Bella, CA 93270
Ref: FEI# 3009866112
Dear Mr. Adam R. Orandi:
On May 21st through May 24th, 2013, investigators from the Unites States Food and Drug Administration (FDA) conducted an inspection of your pistachio processing facility located at 19570 Avenue 88, Terra Bella, California 93270. During the inspection, FDA found that your facility has serious violations of the Current Good Manufacturing Practice (CGMP) regulations for foods, Title 21, Code of Federal Regulations, Part 110 (21 CFR 110). These violations render your pistachio products adulterated within the meaning of section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act (the FFD&C Act), 21 U.S.C. § 342(a)(4), 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. Our investigators’ observations were noted on Form FDA-483, Inspectional Observations, which our investigators issued to you at the conclusion of the inspection.
In early 2013 (prior to this inspection), your firm was associated with three Reportable Food Registry (RFR) reports that detailed positive Salmonella findings detected in two shipments of raw pistachios distributed by your firm. During the inspection, environmental samples were collected from various locations within your processing facility and analyzed. The analysis revealed the presence of Salmonella enterica serotype Senftenberg (S. senftenberg) in seventeen (17) subsamples. Specifically, Pulsed Field Gel Electrophoresis (PFGE) testing determined that a single PFGE pattern of S. senftenberg was present in your facility and that the pattern was present in multiple locations within your facility. The recovery of the same S. senftenberg serotype 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, including numerous product contact surfaces, indicates a high risk of product contamination.
In addition, a cluster of salmonellosis infections reported from January through May 2013, were investigated by local, state, and federal public health and regulatory agencies. Epidemiological data from the outbreak investigation coupled with results of FDA inspection findings outlined below, and analyses from product and environmental samples collected from your processing facility indicate that pistachios were the likely source of the Salmonella outbreak. Therefore, we believe that your pistachios were also adulterated within the meaning of Section 402(a)(1) of the FFD&C Act because they contained the pathogenic bacteria Salmonella, a poisonous or deleterious substance that may render a product injurious to health.
You may find the Code of Federal Regulations, the FFD&C Act, and the CGMP regulations for food through links on FDA’s home page at www.fda.gov.
During the inspection, our investigators observed the following significant violation:
Work-in-process must be handled in a manner that protects against contamination, as required by 21 CFR 110.80(b)(5). However, you failed to handle in-process pistachios in a manner that protects against contamination, as evidenced by:
a. An employee in your roasting room was observed repeatedly touching the bottom of shipping boxes that were resting on the floor and then touching roasted, ready-to-eat, pistachios without washing or sanitizing hands.
b. Maintenance personnel were observed entering and exiting the hand sorting room through a door that opens directly to the outside of the facility. Apparent bird droppings were observed on the floor of the outside areas where maintenance personnel were observed working and entering the hand sorting room. Inside the hand sorting room, two buckets containing floor sweepings of pistachios, dust, and debris, were observed near the hand sorting production lines. During the inspection, you stated that the buckets of floor swept pistachios will be reworked into finished product. The movement of employees from the outside of the facility (where apparent bird droppings were observed) into the hand sorting room may introduce contaminants into your facility and contaminate finished food, particularly based on your practice of reworking pistachios from the floor.
This letter is not intended to be an all-inclusive list of violations at your facility. You are responsible for ensuring that your processing plant operates in compliance with the FFD&C Act and all applicable regulations, including the CGMP regulations for food. You also have a responsibility to use procedures to prevent further violations of the FFD&C Act and all applicable regulations.
You should take prompt action to correct the violations noted in this letter. Failure to promptly correct these violations may result in enforcement action by FDA without further notice. Further actions could include, but are not limited to, seizure and/or injunction.
You should respond in writing within fifteen (15) working days of receipt of this letter describing the specific steps you have taken to correct the noted violations and to prevent these violations or other similar violations from occurring again. Include documentation, including photographs, corrective actions you have taken to date, or other useful information that would assist us in evaluating your corrections. If you cannot complete all corrections within 15 working days, please state the reason for the delay and include a timetable for implementation of those corrections.
Section 743 of the FFD&C Act (21 U.S.C. 379j-31) authorizes FDA to assess and collect fees to cover FDA’s costs for certain activities, including re-inspection-related costs. A re-inspection is one or more inspections conducted subsequent to an inspection that identified noncompliance materially related to a food safety requirement of the FFD&C Act, specifically to determine whether compliance has been achieved. Re-inspection-related costs means all expenses, including administrative expenses, incurred in connection with FDA’s arranging, conducting, and evaluating the results of the re-inspection and assessing and collecting the re-inspection fees (21 U.S.C. 379j-31(a)(2)(B)). For a domestic facility, FDA will assess and collect fees for re-inspection-related costs from the responsible party for the domestic facility. The inspection noted in this letter identified noncompliance materially related to a food safety requirement of the FFD&C Act. Accordingly, FDA may assess fees to cover any re-inspection-related costs.
Please send your reply to the Food and Drug Administration, Attention: Lawton W. Lum, Director, Compliance Branch, 1431 Harbor Bay Parkway, Alameda, CA 94501. If you have questions regarding any issue in this letter, please contact Brandon Bridgman at (510) 337-6794 or Brandon.Bridgman@fda.hhs.gov
Please reference the CMS number 407705 in your response.
Kathleen M. Lewis, J.D.
San Francisco District Office