| || |
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 10, 2015
Mr. Gregory J. Banes
Gold State Nut LLC
1126 Hixon Ave.
Biggs, California 95917
Dear Mr. Banes:
The Food and Drug Administration (FDA) and California Department of Public Health (CDPH) conducted a joint inspection of your facility, located at 1126 Hixon Ave., Biggs, California from April 22 to May 6, 2015. This facility holds walnuts (with associated fumigation); sizes, bleaches, and packs walnuts to be sold in shell; and also cracks, sizes, shells, sorts, and packs walnuts to be sold shelled. During the inspection, FDA collected environmental samples from various areas in your facility. FDA laboratory analysis of the environmental swabs found the presence of Salmonella
, a human pathogen. During the inspection, FDA investigators also observed violations of the Current Good Manufacturing Practice (CGMP) in Manufacturing, Packing, or Holding Human Food regulation, Title 21, Code of Federal Regulations, Part 110 (21 CFR 110). These violations, and our findings of Salmonella
in your facility, cause your walnuts to be adulterated within the meaning of section 402(a)(4) [21 U.S.C. 342(a)(4)] of the Federal Food, Drug and Cosmetic Act (the Act) in that they have been prepared, packed or held under insanitary conditions whereby they may have become contaminated with filth or may have been rendered injurious to health. You can find the Act and the CGMP regulation for foods through links on FDA’s home page at www.fda.gov
Presence of Salmonella
Salmonella is a pathogenic bacterium that is tolerant to desiccation, and is therefore capable of surviving in a dry environment or product. This enables the pathogen to persist in processing environments such as yours. As a result, the likelihood of the pathogen’s survival and subsequent contamination of food is increased and, thus, poses a potential health hazard to consumers when they consume foods contaminated with Salmonella. Consuming these contaminated foods can lead to foodborne illness, which is a public health concern.
Three of 100 environmental swabs we collected from your facility yielded Salmonella. One of the swabs was taken from a cross-beam directly above the belt where all shelled walnuts exit the shell cracker. Our investigators observed debris falling from this cross-beam directly onto the belt below where walnuts exit the cracker during operation. All cracked walnuts pass under this cross-beam.
Two swabs collected from the inside of the reptile enclosure in your office yielded Salmonella. During an interview in your office located within the packing facility, our investigators observed you holding a bearded dragon reptile and peeling off its skin with your bare hands. Following this interview, you were seen touching shelled walnut meats with your bare hands, without first washing your hands. Reptiles are known reservoirs for Salmonella.
FDA’s guidance, “Guidance for Industry: Testing for Salmonella Species in Human Foods and Direct-Human-Contact Animal Foods” addresses testing procedures for Salmonella species in human foods and is available at www.FDA.gov at the following link:
FDA investigators also observed the following significant violations of the Current Good Manufacturing Practice regulation for foods (21 CFR Part 110):
1. You did not take necessary precautions to protect against contamination of food, food contact surfaces and food packaging systems with microorganisms, as required by 21 CFR 110.10(b)(9). Specifically, as noted above, you were observed handling a bearded dragon reptile with your bare hands, and then touching shelled walnut meats with your bare hands without first washing your hands. In addition, an employee walked through standing water on the grounds outside the facility, and then directly into the shelling room, tracking water onto the floors. A shovel used in a bin of shelled walnut meats was seen stored in direct contact with the shelling room floor.
2. You did not handle containers used to convey, hold, or store food in a manner that protects against contamination, as required by 21 CFR 110.80(b)(7). Bins containing in-shell walnuts were sitting directly in standing water before and after fumigation. Some of these bins get stacked on top of other bins, which creates the potential for cross contamination from the bottom of the bins to the areas of the bins that come in contact with the walnuts.
3. You did not clean non-food contact surfaces of equipment as frequently as necessary to protect against contamination of food, as required by 21 CFR 110.35(d)(3). There was a heavy build-up of moist debris on the underside of the conveyor belt which carried shelled walnut meats from sorting to final packaging. Because this belt is comprised of linked segments, the debris can be transferred to the product side of the belt that comes into direct contact with walnuts. You told our investigators that you clean the underside of this belt only once per year.
4. You did not provide your employees with adequate toilet facilities as required by 21 CFR 110.37(d). There was no toilet paper or effective means for drying hands available in the employee restroom. We also observed that employees at your facility sort walnuts with their bare hands.
5. You did not provide your employees with adequate and convenient hand-washing facilities as required by 21 CFR 110.37(e).There was no hand washing facility near the hand sorting operation where we observed your employees sorting walnuts with their bare hands. Only hand sanitizer was available for employees in the sorting area. Hand sanitizer is not a replacement for soap and water.
6. You did not handle work-in process in a manner that protects against contamination, as required by 21 CFR 110.80(b)(5). Specifically, as discussed above, we identified Salmonella in a swab taken from the cross-beam directly above the belt where all shelled walnuts exit the shell cracker. Our investigators observed debris falling from this cross-beam directly onto the belt below where walnuts exit the cracker during operation.
We acknowledge receipt of your response dated May 7, 2015, outlining corrective actions that you have taken. We intend to verify the adequacy of your corrective actions at a future inspection.
The above items are not intended to be an all-inclusive list of the violations at your facility. It is your responsibility to ensure compliance with the applicable laws and regulations administered by FDA. You should take prompt action to correct these violations. Failure to do so may result in regulatory action being initiated by the FDA without further notice. These actions include, but are not limited to, seizure and/or injunction.
Please respond in writing within fifteen (15) working days from your receipt of this letter. Your response should outline the specific actions you are taking to correct these violations and prevent their recurrence. We recommend that you include documentation and details regarding measures that you are taking to prevent the introduction and persistence of Salmonella in your facility. If you cannot complete all corrections before you respond, please explain the reason for your delay and state when you will correct any remaining violations.
Section 743 of the 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 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 Act. Accordingly, FDA may assess fees to cover any re-inspection-related costs.
Your written response should be directed to:
Lawton W. Lum
Director of Compliance
1431 Harbor Bay Parkway
Alameda, California 94502
Refer to the Unique Identification Number CMS 461313 when replying.
If you have any questions about the content of this letter please contact Mr. Sergio Chavez, Compliance Officer at (510) 337-6886.
Kathleen M. Lewis, J.D.