| Public Health Service Food and Drug Administration |
| Minneapolis District Office Central Region 250 Marquette Avenue, Suite 600 Minneapolis, MN 55401 Telephone: (612) 758-7194 FAX: (612) 334-4142 |
Department of Health and Human ServicesDecember 6, 2010
WARNING LETTER
CERTIFIED MAIL
RETURN RECEIPT REQUESTED
Refer to MIN 11 – 07
Weizhen Lin
Owner/Manager
New Wha Ming Trading of MN, Inc.
3430 Winnetka Avenue North
New Hope, Minnesota 55427
Dear Mr. Lin:
The Food and Drug Administration (FDA) conducted an inspection of your food warehouse located at 3430 Winnetka Avenue North, New Hope, Minnesota, on July 9, 12, 16, 19, and 21, 2010. The inspection revealed serious violations of Title 21 of the Code of Federal Regulations (CFR) Part 110 - Current Good Manufacturing Practice in Manufacturing, Packing, or Holding Human Food (CGMP) regulation. Because your food products have been held under insanitary conditions whereby the food products may have become contaminated with filth or 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 may find the Act and FDA’s regulations through links on FDA’s home page at www.fda.gov.
Your significant violations are as follows:
1. Your firm failed to take effective measures to protect against contamination of food on the premises by pests, as required by 21 CFR 110.35(c). During the inspection, our investigators observed live rodents, dead rodents, rodent excreta pellets, rodent nesting and rodent gnawed material, fluorescing urine stains on product packaging and in food, live birds, bird debris, and dead insects. Specifically, our investigators observed the following:
• Live rodents were observed:
• Running behind the ice machine on the southwest wall of the northwest section of the warehouse;
• Under a pallet of yellow peaches in light syrup which was near a pallet of corn starch in the northwest section of the warehouse; and
• Between bags of crax meal on a pallet approximately 20" above the ground in the east central section of the warehouse.
• Dead rodents were observed:
• On and under a pallet of canned peaches and a pallet of canned water chestnuts in the northwestern section of the warehouse;
• In the northeast corner of the warehouse near pallets of placemats and napkins; and
• In several rodent control devices in the northern section of the warehouse.
• Rodent excreta pellets were observed:
• In the southwest corner of the northwestern section of the warehouse;
• On and around a dolly in the southwest corner of the northwestern section of the warehouse;
• Along the west wall of the northern section of the warehouse;
• Near a pallet of canned water chestnuts in the northwestern section of the warehouse;
• On a pallet of canned corn in the northwestern section of the warehouse;
• On pallets of paper pails in the northwestern section of the warehouse;
• On a pallet of canned peaches stored adjacent to a pallet of corn starch in the northwestern section of the warehouse;
• On a pallet of dried noodles in plastic bags stored near the north wall of the northeastern section of the warehouse;
• Along a 3' section of the north wall of the warehouse near pallets of cups and food containers in the northeastern section of the warehouse;
• Behind a pallet of chopsticks on the north wall of the warehouse approximately 8' from the pallet of dried noodles in the northeastern section of the warehouse;
• On a pallet of single serve pepper and sugar packets in the center of the northeastern section of the warehouse;
• Approximately 1' from a pallet of tea in the center of the northeastern section of the warehouse;
• Behind a pallet of salt along the east wall of the northeastern section of the warehouse;
• On a pallet of crax meal approximately 20" off the ground in the northeastern section of the warehouse;
• On a pallet of 50-lb bags of sugar located in the southwest corner of the shipping and receiving area of the firm;
• On a pallet of chow mein noodles in the central section of the southern section of the warehouse; and
• Near a pallet of pastries in cardboard boxes along the south wall of the vegetable cooler.
• Rodent-like nesting materials were found:
• Along the south wall of the northwestern area of the warehouse behind the ice machine;
• In and on a case of canned peaches that was adjacent to a pallet of bagged corn starch in the northwestern section of the warehouse; and
• Along the north wall of the northeastern section of the warehouse near bath tissue.
• Fluorescing urine stains were observed:
• On the pallet holding canned peaches near a pallet of corn starch in the northwestern section of the warehouse;
• On 15 of 26 bags of crax meal located on a pallet approximately 20" off the floor in the northeastern section of the warehouse; and
• On 30 of 200 50-lb bags of sugar on pallets, which were stacked 3 high and 2 or 3 deep, located along the west wall in the shipping and receiving area.
• Rodent-gnawing was observed:
• On the labels of two cans of peaches, as well as through the cardboard of the case containing the peaches, which was flush with a pallet of corn starch, located in the northwestern section of the warehouse near the pallet of corn starch;
• On the labels of six cans and on four of the cases of peaches on a pallet located approximately 20' from the pallet of peaches described in the previous bulleted paragraph above;
• On a case of canned peaches on a pallet located adjacent to the pallet of canned peaches described in the previous bulleted paragraph above in the northwestern section of the warehouse;
• On five individual serving packets of duck sauce located in the northeastern section of the warehouse;
• On eight bags of crax meal on a pallet approximately 20" off the ground in the northeastern section of the warehouse;
• On ten bags of sugar on a pallet located in the southwest corner of the shipping and receiving area of the warehouse; and
• On five bags of sugar on a pallet located in the northwest corner of the shipping and receiving area of the warehouse.
• Insects were observed:
• On bags of corn starch in the northwestern section of the warehouse;
• On a dead rodent in a trap on the west wall of the northwestern section of the warehouse; and
• In the southwest corner of the southwestern section of the warehouse.
• Bird debris, such as droppings and feathers, were observed:
• By cases of individual serving sized packets of salt, pepper, and sweetener in the northeastern section of the warehouse; and
• On cans of condensed milk in the center of the northern section of the warehouse.
• Several live birds were observed flying throughout the warehouse.
In addition, FDA observed open loading doors in the warehouse that may allow pests to gain entry into the building.
2. Your firm failed to maintain buildings, fixtures, or other physical facilities in a sanitary condition and in repair sufficient to prevent food from becoming adulterated, as required by 21 CFR 110.35(a). Specifically, our investigators observed the following:
• Standing water in the walk space behind the coolers and freezer which are located in the southwest corner of the warehouse;
• A plant which appeared to be growing out of the wall of the warehouse, near the standing water;
• Standing water in the meat cooler where broccoli was being stored; and
• Standing water near the emergency exit in the southeast corner of the cooler.
3. Your firm failed to provide, where necessary, adequate screening or other protection against pests, as required by 21 CFR 110.20(b)(7). Specifically, our investigators observed the following:
• A gap approximately 9" long and ½" tall under the loading door on the north side of the warehouse near the lawn mower and oil storage; and
• A gap the length of the loading dock door under the northern-most loading door on the eastern side of the building.
4. Your firm failed to remove litter and waste, and failed to cut weeds or grass within the immediate vicinity of the plant buildings, which may constitute an attractant, breeding place or harborage for pests, as required by 21 CFR 110.20(a)(1). Specifically, our investigators observed the following:
• Weeds along all sides of the building, grown to heights between 6" to 24″;
• On the west side of the building, trees branches had grown to the point where they were within close proximity to the building;
• Brush was piled approximately one foot from the side of the building;
• Refuse, such as spilled fruit and produce, paper and other litter were on the ground directly in front of the loading door near the northeast side of the building;
• Debris, including cement blocks, a tire, and a pole, were stacked in the corner near the south facing loading door.
This letter is not meant to be an all-inclusive list of the violations that may exist at your facility. It is your responsibility to ensure that your facility operates in compliance with the Act and applicable regulations. You should take prompt action to correct these violations. Failure to promptly correct these violations may result in legal action without further notice including, but not limited to, seizure and injunction.
You should notify this office in writing within 15 working days of receipt of this letter of the current status of your corrective actions and the specific steps you have taken or will take to correct the noted violations and to prevent their recurrence. In your response, include, for example, documentation of actions performed by a licensed pest control service or program, documentation of other actions performed to control the entrance of pests, photographs of corrective measures you have put in place and/or any other useful information that would assist us in evaluating your corrections. If you cannot complete all corrective actions 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 Compliance Officer Rebecca L. Caulfield at the address indicated on the letterhead.
Sincerely,
Gerald J. Berg
Director
Minneapolis District
RLC/ccl
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