Inspections, Compliance, Enforcement, and Criminal Investigations
Superior Nut Company, Inc. 14-Oct-03
Public Health Service
|Los Angeles District
Irvine, California 92612-2506
Telephone (949) 608-2900
RETURN RECEIPT REQUESTED
October 14, 2003
Mr. Alvin Rosen, President
Superior Nut Company, Inc.
5200 Valley Boulevard
Los Angeles, CA 90032
Dear Mr. Rosen:
The Food and Drug Administration (FDA) conducted an inspection of your facility located at 5200 Valley Boulevard, Los Angeles, CA 90032 on July 31, 2003 through August 14, 2003. At the conclusion of the inspection you were issued a Form FDA-483 (copy attached) which listed a number of gross insanitary conditions present in your firm at the time of that inspection. These conditions cause the products processed in your facility to be 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), in that they were prepared, packed, or held under insanitary conditions whereby they may have become contaminated with filth.
You may find links to the FDA website at http://www.fda.gov/
The following is a list of the insanitary conditions observed by our investigator during the inspection, (references are to current Good Manufacturing Practice regulations for human foods, Title 21, Code of Federal Regulations (21 CFR)):
1. Failure to take necessary precautions to protect food, food-contact surfaces, food-packaging systems against contamination with foreign substances. [21 CFR 110.10(b)]
a) 4 rodent-like pellets were observed on the outer surface of food-grade mineral oil bottles in the refrigerated storage warehouse, located at the south side of the facility.
b) 22 rodent-like pellets were observed on the floor behind a pallet of sesame seeds along the east wall of the refrigerated storage warehouse.
c) More than 20 rodent-like pellets were observed in the area above the mixing room where unformed boxes used to ship bulk food products were stored.
d) More than 10 rodent-like pellets were observed in between the planks of wood of a pallet stored above bulk bakery ingredient bags, located near the entrance to the mixing room. The pallet contained rolls of plastic used to pack retail bags of trail mix.
e) 4 rodent-like pellets were observed in the far northeast corner of the refrigerated storage warehouse, next to a pallet with boxes of chocolate.
f) 2 rodent-like pellets were observed at the southwest comer of the refrigerated storage warehouse, next to a pallet with boxes of pecans.
2. Failure to provide screening or other protection against pests. [21 CFR 110.20(b)(7)]
a.) The sliding receiving door to the refrigerated warehouse does not seal completely around the doors to exclude pest from entering the refrigerated food warehouse. The molding around the door was damaged and torn with at least a quarter-of-an-inch space opening to the exterior premises.
b.) One of the smaller doors to the cold storage warehouse, located at the south side of the facility, does not close completely and is left ajar to the open receiving area.
c.) There are holes and gaps in the ceiling tiles large enough to accommodate rodent entry into the food storage and food processing areas.
d.) On 8/11/03, a small rodent was observed dead on a glue board near the east wall where buckets of filling were stored.
3. Failure to clean food-contact surfaces as frequently as necessary to protect against contamination of food. [21 CFR 110.35(d)]
a) A large tote was wiped with a towel prior to being filled with trail mix. The inner surfaces of the tote had nut and orange fruit residue from a previous storage of product.
b) The boats which convey product from the hopper to the filling machine were used to fill product while residue from the previous day?s run was left on the food-contact surfaces. Nut residue was not removed from the food-contact surfaces in between processing of different products of peanuts, tree nuts, and dehydrated fruits which may contain sulfur dioxide. Food residue was observed on the conveying boats and totes on multiple days of inspection.
4. Failure to conduct cleaning and sanitizing operations for utensils and equipment in a manner that protects against contamination of food or food-contact surfaces. [21 CFR 110.35(a)]
a) A mixing table was cleaned with a dirty rag and water. No soap or sanitizer was used. Nut residue was observed left on the grate-like surface of the table.
b) Food scoops, food-contact surfaces of the packing machine, and gloves used to mix spices into peanuts were not sanitized as part of the cleaning process.
c) Cleaned lids to the large totes used to store nuts were propped up with the food-contact side against the dirty yellow rail outside in the receiving area where the cleaning was conducted.
5. The material of equipment does not allow proper cleaning and maintenance. [21 CFR 110.40(a)]
a) The tape-wrapped prongs of the packing machine used to form the plastic bags which are filled with trail mix were dirty, torn, and deteriorated.
b) A cardboard box was used to measure spices and peanuts, and observed stored on bulk peanuts, the scale, and the surface of dirty food storage bins.
c) A dirty, blue tarp soiled with an orange-colored residue was used to cover the cleaned mixing table.
6. Storage and use of toxic materials which are not required to maintain clean and sanitary conditions, are unnecessary for use in laboratory testing procedures, are unnecessary for plant and equipment maintenance, and are unnecessary for use in plant operations. [21 CPR 110.35(b)(1)]
Specifically, a container of gasoline was observed stored on top of cleaning hoses for the steam cleaner machine, located next to bulk packaged bakery ingredients.
7. Failure to remove litter and waste that may constitute an attractant, breeding place, or harborage area for pests. Specifically, food debris such as nuts, chocolate, caraway seeds, and flour were observed throughout the refrigerated storage warehouse floor and on food storage cases. [21 CFR 110.20(a)(1)]
The above violations are not meant to be an all-inclusive list of deficiencies in your facility. Other violations can subject the food to legal action. It is your responsibility to assure that all of your products are in compliance with the Act. You should take prompt action to correct the violations observed during FDA?s most recent inspection.
Failure to promptly correct these violations may result in regulatory action without further notice, such as seizure and/or injunction.
Please respond in writing within fifteen (15) days from your receipt of this letter. Your response should include each step that has been taken to completely correct the current violations and to prevent the recurrence of similar violations, the time within which correction will be completed, and any documentation necessary to show that correction has been achieved. If you cannot complete all corrections before you respond, please explain the reason for your delay and the date by which each such item will be corrected and documented state when you will correct any remaining deviations.
Please send your reply to the Food and Drug Administration, Attention: Director, Compliance Branch, 19701 Fairchild Ave, Irvine, California 92612-2506. If you have any questions regarding any issue in this letter, please contact MaryLynn Datoc, Compliance Officer at telephone number 949-608-4428.
Alonza E. Cruse