Inspections, Compliance, Enforcement, and Criminal Investigations
RZM Food Factory 10/25/13
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
October 25, 2013
UNITED PARCEL SERVICE
Mr. William H. Oshiro
RZM Food Factory
440 Pau Hana Road
Makawao, Hawaii 96768
Dear Mr. Oshiro:
The United States Food and Drug Administration (FDA) conducted an inspection of your food processing facility, located at 440 Pau Hana Road, Makawao, Hawaii, from June 25-27, 2013. During the inspection we documented insanitary conditions and practices that render your mung bean, clover, alfalfa, and radish sprouts 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 its implementing regulations at www.fda.gov.
The following insanitary conditions were documented:
1. You told our investigator that sprout trays, utensils and processing equipment that come into direct contact with sprouts are not washed or sanitized, but simply rinsed. The material used to line one of the sprout growing trays was cracked and uneven, with visible sprout residue. In addition, the cement water-trough used to wash harvested, ready-to-eat sprouts was pitted with exposed aggregate and had visibly peeling paint. Similar observations, regarding the poor conditions of the processing equipment (e.g. the deteriorated and peeling painted concrete surface of the wash-trough), were made during investigations dating back through 2001. These conditions allow for the development of harborage sites for pathogens, such as Listeria monocytogenes, and may have resulted in the contamination of your sprouts with pathogens.
2. The tank used to hold and distribute irrigation water for your ready-to-eat sprout growing process is corroded with visible flaking rust, and is placed directly beneath the roof, open and unprotected from pests. The condition of the tank is such that the water supply may have become contaminated with harmful bacteria or extraneous matter.
In addition to the violations discussed we have comments related to general house-keeping in and around your facility. Our investigator documented containers filled with water scattered on the floor and empty cardboard boxes inside and outside the facility. These conditions create harborage areas for rodents and other pests, and do not allow the areas to be properly monitored or cleaned.
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 of your products and/or injunction.
Information on proper handling and controls for sprout manufacturing can be found in our Guidance for Industry: Reducing Microbial Food Safety Hazards for Sprouted Seeds, (located online at http://www.fda.gov/Food/GuidanceComplianceRegulatoryInformation/GuidanceDocuments/ProduceandPlanProducts/ucm120244.htm) and Guidance for Industry: Sampling and Microbial Testing of Spent Irrigation Water During Sprout Production (located online at http://www.fda.gov/Food/GuidanceComplianceRegulatoryInformation/GuidanceDocuments/ProduceandPlanProducts/ucm120246.htm), both dated October 27, 1999. Also, the University of California at Davis, in cooperation with FDA, developed a series of online videos related to sprout safety that can be found at: http://postharvest.ucdavis.edu/libraries/video/. The documents and online videos are considered guidance and are designed to assist you in complying with the Food, Drug, and Cosmetic Act.
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. If you cannot complete all corrections within 15 working days, state the reason for your delay and the time within which corrections will be completed.
Section 743 of the Act (21 U.S.C. § 379j-31) authorizes FDA to assess and collect fees to cover 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 (CMS409667) when replying.
If you have any questions about the content of this letter please contact Ms. Aleta T. Flores, Compliance Officer at (510) 337-6821.
Kathleen M. Lewis, J.D.