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U.S. Department of Health and Human Services

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Enforcement Actions

International Specialty Supply Holding, Inc. 6/12/12

  

Department of Health and Human Services' logoDepartment of Health and Human Services

Public Health Service
Food and Drug Administration
 

New Orleans District
404 BNA Drive
Building 200 – Suite 500
Nashville, TN  37217

Telephone: (615) 366-7801
        FAX:  (615) 366-7802

June 12, 2012

WARNING LETTER NO. 2012-NOL-23

 
UNITED PARCEL SERVICE
Delivery Signature Requested

Robert L. Rust, CEO
International Specialty Supply Holding, Inc.
820 East 20th Street
Cookeville, Tennessee 38501

Dear Mr. Rust:

Investigators from the U.S. Food and Drug Administration (FDA) conducted an inspection of your sprout growing facility, located at 820 East 20th Street, Cookeville, Tennessee, on February 8-10, 13-17, 22-24, 27, and 28, 2012.  During our inspection we observed insanitary conditions and practices which cause your fresh cut products to be adulterated within the meaning of Section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act (the Act) [21 United States Code § 342(a)(4)] because they were prepared, packed, or held under insanitary conditions whereby they may have become contaminated with filth or rendered injurious to health as outlined below. 

1. Condensation was dripping from walls and/or ceilings in the Seed Receiving Room, Seed Storage Room, Mung Bean Processing Area, and especially in your green sprout operation where sprouts were stored directly under pipes with condensation build-up.  Further, water was pooling on the floor and mold was accumulating in the Seed Receiving Room.  Condensate and standing water may foster the growth of and contribute to the spread of pathogens, for example, Listeria monocytogenes.  Condensate dripping onto product may contaminate product directly and/or contaminate equipment or personnel, which can serve as routes of contamination. 

2. You must take effective measures to exclude pests from the processing area and to protect against contamination of foods in order to comply with 21 CFR 110.35(c).  However we observed:

a. An open culvert, approximately 18 inches in diameter, under a rack in the northeast corner of the room which leads directly to the exterior of the building was partially covered by a screen on the exterior of the facility. 
b. Four live cockroaches next to the broccoli dryer and in close proximity to food packaging material. 
c. Dead crickets, spiders, and cockroaches along the walls and in glue traps in the seed storage warehouses, as well as spider webs along the walls and on racks near where seed used for sprouting was stored.
d. Evidence of termite dirt trails along the north wall near food packaging material in the food packaging warehouse.

3. You must have adequate sanitary facilities to comply with 21 CFR 10.37.  However:

a. The men’s restroom, located on the south end of the food packaging warehouse, opens directly into the warehouse/processing area where dried broccoli is processed.  The door was not self closing and the door knob had been removed.
b. The urinals, toilets, sinks, walls, and floors in the men’s restroom located on the south end of the food packaging warehouse were visually dirty.

4. Sprouts and seed may have become contaminated as a result of direct or indirect contact with insanitary surfaces, as evidenced by:

a. Product build-up under the plastic cover and underneath the riveted screening on the de-hulling machine/wash tank used for processing mung beans.
b. A thick layer of dust was observed on pipes and ceiling directly above stored food packaging material and where dried broccoli was processed.

5. Sprouts and seed may have been contaminated, as evidenced by:

a. An opening of approximately nine square inches was observed in the ceiling where a down spout broke away from the ceiling in the Seed Storage Warehouse number 2.
b. Several holes were observed in the Seed Storage Warehouse ceiling under which seeds were directly stored.
c. All six of the fans in the mung bean growing room were observed to be corroded with rust. Two of these fans were located directly over your mung bean product. 
d. Flaking/peeling paint was observed on the north, south, east, and west walls of the room were sprouts are stored.  Uncovered sprouts were observed stored directly against the east wall.
e. Dust on walls, ceiling, and on the plastic covering your firm’s seed products was observed in the seed storage warehouses. 

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 correct these violations 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 of the corrective actions you have taken to date. Mr. Raymond C. Jones, General Manager, reported during the conclusion of the inspection that the objectionable conditions would be corrected.  If your corrections will occur over time, please state the reason for the delay and include a timetable for implementation of those corrections. 

FDA has developed guidance to assist sprout manufacturers.  Please find FDA’s guidance by following the appropriate links on FDA’s Internet home page at http://www.fda.gov.  Also, FDA recommends that seeds for sprout production be grown under good agricultural practices (GAPs) in order to minimize the likelihood they will contain pathogenic bacteria. For more information on GAPs, see FDA's 1998 "Guidance for Industry:  Guide to Minimize Microbial Food Safety Hazards for Fresh Fruits and Vegetables1"

In cooperation with FDA, University of California at Davis has developed of 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 Food, Drug, and Cosmetic Act. 
Please send your reply to the Food and Drug Administration, Attention: Mark W. Rivero, at the address above.  If you have questions regarding any issues in this letter, please contact Mr. Rivero at (504) 832-1103.

Sincerely,

/s/

Patricia K. Schafer
District Director
New Orleans District

Enclosure:  FORM FDA 483 dated February 28, 2012
 
cc: Raymond C. Jones, General Manager
     International Specialty Supply Holding, Inc.
     820 East 20th Street
     Cookeville, Tennessee 38501