Arizona Hydroponic Farming, LLC 2/11/13
| || |
Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
Los Angeles District
Irvine, CA 92612
VIA UNITED PARCEL SERVICE
February 11, 2013 W/L 21-13
Ting Hsiao, Owner
Arizona Hydroponic Farming, LLC
P.O. Box 935
Eloy, AZ 85131
Dear Mr. Hsiao:
The U.S. Food and Drug Administration (FDA) conducted inspections of your sprout growing facility located at 119 S. Sunshine Blvd., Eloy, AZ on September 18-20, September 28-October 03, and October 23-26, 2012. During the inspection ending September 20, 2012, FDA collected several finished alfalfa sprouts, and spent irrigation water samples from your facility. We notified you on September 27, 2012, that our laboratory analyses of the samples yielded Salmonella Cubana. Foods containing Salmonella are adulterated within the meaning of section 402(a)(1) of the Federal Food, Drug, and Cosmetic Act (the Act) [ 21 U.S.C. 342(a)(1)], in that they contain a poisonous or deleterious substance (Salmonella) which may render them injurious to health.
Subsequent to our findings of Salmonella Cubana, FDA participated in epidemiological and traceback investigations with affected states and the Centers for Disease Control (CDC). Through the epidemiological investigation, sprouts were linked to an outbreak of human infections of Salmonella Cubana. This outbreak sickened approximately 14 people in three states between July 30, 2012, and October 25, 2012. Through traceback investigation, Arizona Hydroponic Farming brand alfalfa sprouts were identified as the vehicle. Four out of five ill persons with food histories reported consuming sprouts in the 7 days before illness onset. One case-patient purchased Arizona Hydroponic Farming alfalfa sprouts from a grocer that stated they only purchased sprouts from your firm. We note that the majority of your sprouts are distributed to customers in the affected states.
During the inspections ending October 03, 2012, and October 26, 2012, our Investigators also documented insanitary conditions and practices that may have contributed to contamination of your sprouts with pathogens. Accordingly, the sprouts grown in your facility are also 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)] because they have been prepared, packed, or held under insanitary conditions whereby they may have been contaminated with filth or rendered injurious to health. You can find the Act through links on FDA’s homepage at www.fda.gov
The following insanitary conditions and practices were observed:
Inspection ending October 03, 2012
Standing water of 2 to 3 inches was observed on the floor in the sprout growing room, immediately under the bottom racks of growing sprouts. This water can splash onto the sprouts by employees walking by these racks. Standing water may serve as a reservoir of pathogens as well as a route of contamination. Employees and equipment may contaminate the sprouts or food contact surfaces through splashing.
Your response received October 09, 2012, to the FDA-483 issued to you on October 03, 2012, stated that you would repair your floors. However, you did not provide documentation that you had repaired the floor.
Inspection ending October 26, 2012
The water for your evaporative coolers comes from a tub located on the roof. The tub was uncovered, the water was dirty, green, and there were birds around the tub. This water enters the plant in the form of a mist. The water is likely to have come in contact with uncovered sprouts and sprouting equipment. In your November 9, 2012 response, you indicate that you now only run sanitized well water through the evaporative cooler. However, you did not document the changes.
There was animal excrement on an area sloping towards the well head of the well used to irrigate your sprouts. There were two large dogs roaming the property. A pipe at the well head was open on top and stuck up several inches from the ground. Further, there was no cement apron around your well head to protect it from contamination. In your November 9, 2012 response, you indicate that you have removed the open pipe and fenced in the dogs. However, you did not document the changes.
Water from the hand washing sink drain was observed splashing on the drain trough, near the stored cleaned trays and panels for holding sprouts.
Floor drains were open to the outside of your building and the openings were not tightly sealed.
Drums and tubs used for sprouting had heavy residue. Further, the drums could not be adequately cleaned because they were gouged and rough.
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 notify this office 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, other materials, of all of the corrective actions you have taken to-date. If your planned corrections will occur over time, please state the reason for the delay and include a timetable for implementation of those corrections.
We note that when you were notified that your product yielded Salmonella Cubana, you agreed to destroy product that you had at your firm and stated that no product was expected to be on the market.
In your November 9, 2012 response, to the FDA-483, you provided us with a journal article in support of the method of seed disinfection that you are using. FDA acknowledges that there are validated methods of seed disinfection in addition to the one we recommend in our guidance. You did not include documentation that you are monitoring the critical parameters of this disinfection process. We recommend that you ascertain that you are effectively implementing the method by carefully monitoring all of the critical parameters and that you verify the process is working with microbial samples as recommended in our guidance.
We recommend that you conduct a root cause analysis to determine the source(s) and route(s) of contamination so that you can prevent future contamination.
During the inspection, our Investigators provided you a copy of the Guidance for Industry: Reducing Microbial Food Safety Hazards for Sprouted Seeds
, and Guidance for Industry: Sampling and Microbial Testing of Spent Irrigation Water During Sprout Production
, both dated October 27, 1999. In cooperation with FDA, University of California at Davis also developed a series of videos related to sprout safety (http://postharvest.ucdavis.edu/libraries/video/
). These documents are considered guidance and are designed to assist you in complying with the Federal Food, Drug, and Cosmetic Act. If you plan to implement an alternative approach to treating seed to prevent your products from becoming adulterated please provide us with your method and documentation supporting the validity of the method. We also request that you provide a copy of your sampling schedule and testing method to the address below. If you have questions regarding this letter, please contact Dr. Raymond W. Brullo at 949-608-2918 or at email@example.com
Please send your reply to the U.S. Food and Drug Administration:
Blake Bevill, Director, Compliance Branch
Irvine, CA 92612
Alonza E. Cruse
Arizona Department of Health Services
150 North 18th Avenue
Phoenix, Arizona 85007
Arizona State Department of Agriculture
1688 West Adams Street
Phoenix, AZ 85007
Pinal County Public Health Services District
P.O. Box 2945
971 N. Jason Lopez Circle, Bldg. D
Florence, AZ 85132