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WARNING LETTER

Kwong Tung Foods, Inc.


Recipient:
Kwong Tung Foods, Inc.


United States

Issuing Office:
Minneapolis District Office

United States


  

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

Public Health Service
Food and Drug Administration
 
Minneapolis District Office
Central Region
250 Marquette Avenue, Suite 600
Minneapolis, MN 55401
Telephone: (612) 334-4100
FAX: (612) 334-4142 

 

April 9, 2015
 
 
WARNING LETTER
 
 
Via UPS Overnight Delivery                                     
Refer to MIN 15 - 09
 
 
Victor C. Wang
Owner
Kwong Tung Foods, Inc.
1840 E. 38th Street
Minneapolis, Minnesota 55407
 
Dear Mr. Wang:
 
The Food and Drug Administration (FDA) conducted an inspection of Kwong Tung Foods, Inc. located at 1840 E. 38th Street, Minneapolis, Minnesota, on November 17-20, 24 and December 18, 2014. Our inspection found your firm is a manufacturer of egg noodles, wheat noodles, rice noodles, and sprouts. The inspection revealed serious violations of Title 21 of the Code of Federal Regulations (21 CFR) Part 110 - Current Good Manufacturing Practice in Manufacturing, Packing, or Holding Human Food (CGMP) regulation.  During this inspection samples were collected that documented rodent evidence throughout the facility:  sample INV882614 showed the presence of rodent excreta pellets and rodent hair; analysis of sample 828659, mung bean seeds, shows the presence of rodent gnawing, rodent hair, rodent urine and excreta pellets; and analysis of sample 828660, flour, shows the presence of rodent excreta pellets and live and dead drugstore beetles, Stegobium panecium (L).  
 
Because your noodles and sprouts have been prepared, packed or held under insanitary conditions whereby they may have been rendered injurious to health, your food products are 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).  You can find the Act and FDA’s regulations through links on FDA’s home page at www.fda.gov
 
We observed the following conditions and practices during the inspection of your facility which may result in the contamination of your products:
 
1.    Failure to take effective measures to exclude pests, as required by 21 CFR 110.35(c). Specifically,
  • On November 17, 2014:
o   Rodent excreta pellets too numerous to count and a stain fluorescing bright yellow under ultraviolet light that is consistent with rodent urine were observed along the floor of the Boiler Room directly adjacent to pallets of long grain rice.
o   Rodent excreta pellets too numerous to count were observed on the floor under racking along the entire length of the east wall in the Back Storage area.
o   A dead mouse was observed on the floor adjacent to the water storage reservoir in the Back Storage area.
o   A dead mouse and a gnawed bait pouch were observed on the floor adjacent to the fresh air vent leading to the Mung Bean Sprout Gowning Room. 
o   Rodent excreta pellets were observed along the west wall adjacent to an equipment storage rack.
  • On November 18, 2014:
o   A live beetle-like insect was observed on the noodle machine electrical cord.
o   A partial bag of bakers flour was stored on a pallet. The bag was closed by rolling down the top of the bag. Upon unrolling the top of the bag, apparent rodent excreta pellets were observed in the product, and on and around the pallet.
o   Rodent excreta pellets were observed under the east wall equipment storage rack. 
o   Rodent excreta pellets too numerous to count were observed in the drain trough that ran the length of the room.
o   Rodent excreta pellets too numerous to count were observed in the drain trough that ran the length of the Rice Noodle Production Area. 
o   Rodent excreta pellets were observed on and around the equipment storage rack in the west wall in the Rice Noodle Production Area.
  • On November 19, 2014:
o   Rodent excreta pellets were observed in the southeast corner directly adjacent to the storage rack in the storage room.
  • On November 24, 2014:
o   Dead beetle-like insects were observed in a bucket containing chow mein noodles located in the Wheat Noodle Processing Room. 
o   Beetle-like insects were noted in the bottom of a blue ingredient bin that held an open bag of whole wheat flour.
o   Live and dead beetle-like insects were noted on the noodle machine.
o   Rodent excreta pellets were observed on a mixed pallet containing bags of long grained rice, brown rice, potato starch, and along the west wall of the hall directly adjacent to the mixed pallet.
 
2.    Failure to store and dispose of rubbish to minimize the potential for waste becoming an attractant and harborage or breeding place for pests, as required by 21 CFR 110.37(f).  Specifically, ingredients that are no longer in use, e.g., rye flour, rye bran flour, brown rice, whole wheat, etc., are stored in the Wheat Noodle Production area and Main Hall.  These products were noted with rodent gnaw holes; and rodent excreta pellets were observed on the pallets. In addition, used flour bags that may serve as an attractant and harborage area for pests are stored in the Wheat Noodle Production area and Warehouse.
 
3.    Failure to maintain gloves used in food handling in an intact, clean, and sanitary condition, as required by 21 CFR 110.10(b)(5). For example, on October 24, 2014, employees were observed re-using single service gloves and then using their gloved hands to manipulate and package finished steamed egg noodles. The gloves were placed on the packaging table and on a tray on the lower rack of the packaging table when not in use and re-used without being cleaned or sanitized.  
 
4.    Failure to wear suitable outer garments to protect against contamination of food, food contact surfaces, and food packaging materials, as required by 21 CFR 110.10(b)(1). For example, employees wore single service sleeve guards that were observed to be covered with old product buildup and filth while they were packaging finished steamed egg noodles. The sleeve guards came into direct contact with the finished steamed egg noodles as they were being packaged. The sleeve guards are re-used without being cleaned or sanitized; they are also used in the mung bean sprout production area and are stored unprotected on a shelf in the Main Hallway. 
 
5.    Failure to sanitize food-contact surfaces, including utensils and equipment, as frequently as necessary to protect against contamination of food, as required by 21 CFR 110.35(d). Specifically,
  • On November 17, 2014, rice noodle equipment was observed with old product build-up on the mill, in the slurry and mix tanks, on the surfaces of the steam tunnel, on the roller conveyors, and in the drying chamber and the control buttons. Rice noodles were last manufactured two days earlier.
  • The stainless steel trough used to cool fried chow mein noodles was observed to contain old product. Chow mein noodles are manufactured (b)(4) every (b)(4) weeks.
  • Wheat noodle equipment was observed encrusted with old product build-up in the mixer, scrape surface hopper, press, sheeters, conveyor, support frames and control buttons. The equipment was wiped down with isopropyl alcohol on November 24, 2014, prior to use; old product build-up remained on the food contact surfaces of the mixer, hopper, press, sheeters and conveyor; steamed egg noodles were subsequently manufactured on this equipment.
6.    Failure to properly maintain plant equipment as to be adequately cleanable and properly maintained, as required by 21 CFR 110.40(a). For example:
  • The food contact surface of the wheat noodle mixer and the surface of the hopper have standard and countersunk screws with recesses exhibiting built-up, encrusted product residues.
  • The rice noodle drying chamber does not have access ports to facilitate cleaning. Sheets of rice noodles, oil and filth were observed throughout the chamber.  
7.    Failure to take effective measures to protect against the inclusion of metal in food, as required by 21 CFR 110.80(b)(8). Specifically, metal links were observed to be missing from the metal conveyor on the noodle fryer.
 
8.    Failure to provide safety-type light bulbs and lighting fixtures suspended over exposed food, as required by 21 CFR 110.20(b)(5). Specifically, on November 24, 2014, steamed egg noodles were being manufactured on equipment below unprotected lights.
 
This letter is not intended to include an exhaustive list of the violations at your facility.  It is your responsibility to ensure compliance with applicable food safety laws and regulations administered by FDA.  You should take prompt action to correct the violations described in this letter and to establish procedures to ensure that these violations do not recur. Failure to do so may result in regulatory action such as seizure and/or injunction without further notice.
 
Further, 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 non-compliance 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 non-compliance materially related to a food safety requirement of the Act. Accordingly, FDA may assess fees to cover any re-inspection-related costs.
 
In addition to the violations discussed above, we have the following comments:
 
You stated that you rinse the raw beans intended for sprout production with a chlorine solution of approximately (b)(4) ppm. On-site FDA testing of your chlorine rinse revealed that the actual concentration was lower than 25 ppm. FDA recommends rinsing the beans with 20,000 ppm calcium hypochlorite solution for the reduction of pathogens in seeds or sprouts.
 
A black mold-like substance and old product residue were observed after sanitation and during production on the green rubber paddles of the air knife, on the framework of the incline conveyor, and on the underside of the conveyor belt used to move sprouts.  Filth, debris, and other contamination may be transferred from the equipment to the finished mung bean sprouts.
 
Sample INV874245, mung bean seeds, was analyzed for Listeria spp. and Salmonella spp.; none was detected. Sample 874244, mung bean sprouts, and samples INV 887066 and INV887067, spent irrigation water, were analyzed for Listeria spp., Salmonella spp., and E. coli O157:H7; none was detected.  
 
For additional information and guidance for industry concerning sprouts, please refer to FDA’s home page at www.fda.gov.
 
Please notify this office in writing within 15 working days from the date you receive this letter of the specific steps you have taken to correct the noted violations, including an explanation of how you plan to prevent these violations, or other, similar, violations, from occurring again.  Include documentation of the corrective actions you have taken.  If your planned corrections will occur over time, please include a timetable for implementation of those corrections.  If corrective action cannot be completed within 15 working days, state the reason for the delay and the time within which the corrections will be completed.
 
Your reply should be directed to the Food and Drug Administration, Attention: Demetria Lueneburg, Compliance Officer, at the address indicated on the letterhead. If you have any questions regarding any issues in this letter, please contact Ms. Lueneburg at (612) 758-7210.
 
Sincerely,
/S/ 
Michael Dutcher, DVM
Director
Minneapolis District