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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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The Nut Factory Inc. 4/11/12

  

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

Public Health Service
Food and Drug Administration
 Seattle District
Pacific Region
22201 23rd Drive SE
Bothell, WA 98021-4421
Telephone: 425-486-8788
FAX: 425-483-4996
 
 
April 11, 2012
 
 
 
CERTIFIED MAIL
RETURN RECEIPT REQUESTED
 
In reply refer to Warning Letter SEA 12-22
 
Eugene Cohen, President and Owner
The Nut Factory, Inc.
P.O. Box 815
Greenacres, Washington 99016
 
WARNING LETTER
 
Dear Mr. Cohen:
 
The Food and Drug Administration (FDA) conducted an inspection of your food manufacturing firm located at 19425 East Broadway Avenue, Greenacres, Washington, on January 09-12, 2012. During the inspection, the FDA investigator documented serious violations of the Current Good Manufacturing Practice (CGMP) in Manufacturing, Packing, or Holding Human Food, Title 21, Code of Federal Regulations (CFR), Part 110 (21 CFR 110). These violations cause the food products produced in your facility to be 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 rendered injurious to health. You can find the Act and the FDA regulations through links in FDA's homepage at www.fda.gov
 
Your significant violations are as follows:
 
1. As required by 21 CFR 110.35(c), you must not allow pests in any area of a food plant. Effective measures must be taken to exclude pests from the processing areas and to protect against the contamination of food on the premises by pests. However, our investigator observed the following evidence of a lack of pest control:

a. One dead rodent was observed partially inside a pest control trap along the north wall in the Finished Product Packaging and Storage area.

b. One dead rodent was observed on the floor along the north wall of the Maintenance Room. This room is adjacent to the processing area.

c. One dead rodent was observed in the northwest corner of the second floor loft above the offices. This loft area stores material for packaging.

d. Large numbers of rodent excreta pellets (REPs) were observed throughout your firm. For example;

i. REPs were observed on, under and around pallets in the Raw Ingredient Storage Area.

ii. REPs were observed on a pallet where an open case of Hickory Mesquite Seasoning was being stored.

iii. REPs were observed on the floor in the southeast comer of the Sunflower Room.

iv. REPs were observed on and next to decorative cardboard boxes used for packaging finished product and on clear plastic bags used for finished product packaging.

v. REPs were observed on the floor under a wire rack along the west wall of the Finished Product Storage Area.

vi. REPs were observed on the floor along the north wall of the Raw Ingredient Storage Area.

vii. REPs were observed under the stairs in the Receiving Area

viii. REPs were observed on a pallet and on the floor along the south wall of the Shipping Area.

ix. REPs were observed on the floor along the east wall and on shelving along the west wall of the Tin Room.

x. REPs were observed in the northwest comer of the second floor storage loft.

xi. REPs were observed inside a cardboard box containing plastic tin inserts.

xii. REPs were observed on the floor in the Maintenance Room.

xiii. REPs, food particles and other debris were observed accumulated in the northeast comer of the Receiving Area near the washer and dryer.

xiv. A REP was observed on the working surface of a heat sealing machine in the Packing Room.

We acknowledge the receipt of your written response dated January 16, 2012, to the FORM FDA-483, Inspectional Observations, issued to you at the close of the inspection. Your response to this observation is inadequate in that you state you have removed the REPs, cleaned the areas where REPs were found and discarded some packing material on which REPs had been observed.

However, your response does not adequately address methods used to remove contamination following the removal of REPs, or how you will prevent pests from entering your facility in the future. This violation was observed and cited in the previous FDA inspection in March 2010.

2. As required by 21 CFR 110.35(a), you must clean and sanitize utensils and equipment in a manner that protects against contamination of food, food-contact surfaces or food packaging material. However, our investigator observed the following during the inspection:

a. A greasy film was observed on three marble work surfaces in the Chocolate Room.

b. Two kettles in the Sugar Room were observed soiled with residue from the previous week's production.

c. Metal pails and scoops in the Packaging Area were observed soiled with product residue.

d. Baskets in the oil roasters in the Roasting Room contained nuts and nut skins from production at least three days prior to the inspection.

e. The almond slicer used to slice roasted almonds was observed to have a thick product build-up following a cleaning process on 11/09/2012.

f. The popcorn maker in the Roasting Room was observed soiled with food debris from a previous production day.

g. Metal bins used to store raw and finished product were observed with food debris lodged in the crease at the base of the bins.

h. The tops and sides of plastic lids used to cover metal bins containing raw and finished product were observed with a layer of debris.

i. A scoop with food debris and a soiled terry cloth towel were used to collect nuts from the table and put them in a box during a repacking operation.

j. The sunflower roasting machine was observed with food residue on the inside of the machine, on the underside of the conveyor belt and in the space under the conveyor belt.

We acknowledge the receipt of your written response to the FORM FDA-483, lnspectional Observations, issued to you at the close of the inspection. Your response is inadequate in that you have not provided specific details on corrective actions you have taken or will take to prevent this violation from recurring in the future.

3. As required by 21 CFR 110.35(e), cleaned and sanitized portable equipment with food contact surfaces and utensils should be stored in a location and in a manner that protects food-contact surfaces from contamination. However, our investigator observed cleaned dishes being air dried and stored on the top of the soiled conveyor belt of the sunflower roasting machine.

We acknowledge the receipt of your written response to the FORM FDA-483, Inspectional Observations, issued to you at the close of the inspection. Your response indicates a correction was made during the inspection. However, based on the evidence of rodent activity inside your facility, placing clean dishes on the floor is not an adequate correction.

4. As required by 21 CFR 110.40(b), seams on food-contact surfaces must be smoothly bonded or maintained so as to minimize the accumulation of food particles; dirt and organic matter. However, our investigator observed (b)(4) tables in the Roasting Room used to cool product after processing had sharp corners and seams bonded in a manner such that food debris collected in the corners which was not removed during cleaning operations.

We acknowledge the receipt of your written response to the FORM FDA-483, lnspectional Observations, issued to you at the close of the inspection. In your response, you state new equipment will be purchased within (b)(4) months. This response is partially adequate in that you plan to replace the equipment. However, food particles collecting in the rough welds of these tables may be a source of finished product contamination and a potential food source for pests.

5. As required by 21 CFR 110.35(a), you must maintain buildings, fixtures, and other physical facilities in a sanitary condition and keep them in repair sufficient to prevent food from becoming adulterated. However, our investigator observed the following during the inspection:

a. An opening in the wall under the three compartment sink in the Sunflower Room where the exposed pipe and surrounding surfaces were soiled with what appeared to be mold.

b. An opening on the west wall of the roasting room approximately fifteen inches tall and twelve inches wide with accumulated food and other debris.

c. A sooty deposit on the walls and ceilings of the Roasting Room.

d. Two sets of strip curtains between the Roasting Room and the Ingredient Storage Area soiled with apparent food residue.

e. Strip curtains used to cover the warming oil in the Roasting Room soiled with apparent food debris.

f. Strip curtains between the Chocolate Room and the Sugar Room soiled with chocolate and other food debris.

We acknowledge the receipt of your written response to the FORM FDA-483, lnspectional Observations, issued to you at the close of the inspection. Your response to this observation is inadequate in that you do not indicate that these areas have been cleaned or sanitized. This violation was observed and cited in the previous FDA inspection of March 2010.

6. As required by 21 CFR 110.10(b)(6), all persons working in direct contact with food, food-contact surfaces, and food-packaging materials must wear, where appropriate, and in an effective manner, hair nets or other effective hair restraints. However, our investigator observed an employee repacking 25 pounds of hazelnuts and 50 pounds of cashews without a hair restraint or hair net.

We acknowledge the receipt of your written response to the form FDA-483, lnspectional Observations, issued to you at the close of the inspection. Your response fails to address this observation.

This letter may not list all the violations at your facility. You are responsible for ensuring that your food facility operates in compliance with the Act and the Current Good Manufacturing Practice regulations (21 CFR Part 110) and the Food Labeling regulations (21 CFR Part 101). You also have a responsibility to use procedures to prevent further violations of the Act and all applicable regulations.

Failure to implement lasting corrective action of these violations may result in regulatory action being initiated by FDA without further notice. For example, we may take further action to seize your products and/or enjoin your firm from operating.

In addition, we note the following labeling issues:

1. Your Swiss Mix, Mexicali Corn, and Toasted Com products fail to bear the common or usual name of each ingredient as required by 21 CFR 101.4(b). Specifically:

a. Your Swiss Mix product label declares the ingredient "part hydrog palm kernel oil", an abbreviation of a specific common or usual name, and your Mexicali Corn and Toasted Corn product labels declare the ingredient "vegetable oil". According to 21 CFR 101.4(b)(14), each individual fat and/or oil ingredient of a food intended for human consumption shall be declared by its specific common or usual name (e.g., "beef fat," "cottonseed oil", "partially hydrogenated palm kernel oil").

b. Your Sierra Mix ingredient label declares the ingredients "gran" and "sa", which appear to be abbreviations of a specific common or usual name. According to 21 CFR 101.4(b), the label must bear the specific name of each ingredient (e.g., "salt").

c. Your Sierra Mix product is made with ingredients, some of which are themselves comprised of multiple ingredients,. including chili crescents. However, the chili crescent sub-ingredients are not listed on the product label in accordance with 21 CFR 101.4(b)(2). Additionally, Sierra Mix product label incorrectly lists the sub-ingredients for the ingredient "sesame sticks". The sub-ingredients for the "sesame sticks" ingredient are listed between dashes after the name of the main ingredient, "sesame sticks - flour, sesame seeds, bulgar [sic] wheat, salt, garlic/onion powder, soy, gran [sic], garlic, beet color, turmeric, soybean oil-".

d. Your Swiss Mix product label declares "artif color". However, 21 CFR 101.4(b) does not permit the collective listing of color ingredients.

e. Your Sierra Mix product label ingredient declaration includes several misspelled ingredients, e.g., "monosodium glutonate", (monosodium glutamate), and "hydrolized corn" (hydrolyzed corn).

The requirement to list sub-ingredients may be met by either parenthetically listing the component ingredients after the common or usual name of the main ingredient [21 CFR 101.4(b)(2)(i)], or by listing the component ingredients without listing the ingredient itself [21 CFR 101.4(b)(2)(ii)]. Under the first alternative, the component ingredients must be listed in descending order of predominance within the multi-component ingredient and under the second alternative, the component ingredients must be listed in descending order of predominance in the finished food.

2. Your Sierra Mix product label declares "bbq flavoring", and your Mexicali Corn product label declares "flavorings". However, the finished product labels for both products fail to declare whether or not these are natural or artificial flavors as required under 21 CFR 101.22(h)(1).

3. The net weight of your Mexicali Corn, Toasted Corn, Swiss Mix, and Sierra Mix product labels should be followed by the metric equivalent in parenthesis.

4. Your Mexicali Corn, Toasted Corn, Swiss Mix, and Sierra Mix product labels fail to bear the name and place of business of the manufacturer, packer, or distributor in accordance with 21 CFR 101.5. Specifically, if the street address is not provided as part of the name and address of the manufacturer, it must be shown in a current city directory or telephone directory.

We request that you notify this office in writing, within 15 working days from your receipt of this letter, of the current status of your corrective actions and the specific steps you have taken to correct the noted violations. In your response, include documentation such as certification of actions performed by a licensed exterminator, other actions performed to control unauthorized entrance of pests, plans on how you plan to protect food products from possible contamination, and/or any other useful information that would assist us in evaluating your corrections. If you cannot complete all corrections before you respond, we expect that you will explain the reason for your delay and state when you will correct any remaining violations. 

Please send your reply to the Food and Drug Administration, Attention: Cynthia White, Compliance Officer, 22201 23rd Drive SE, Bothell, Washington 98021-4421. If you have questions regarding any issue in this letter, please contact Cynthia White at (425) 302-0322.
 
Sincerely,
/S/ 
Charles M. Breen
District Director