| 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 |
Department of Health and Human ServicesFebruary 23, 2010
VIA CERTIFIED MAIL
RETURN RECEIPT REQUESTED
In reply refer to Warning Letter SEA 10-15
Do Jung Hwang, President
Seoul Trading, Inc.
1610 Boundary Road
Auburn, Washington 98001-6582
WARNING LETTER
Dear Mr. Hwang:
We inspected your food storage, repacking, and importer facility, located at 1610 Boundary Road, Auburn, Washington, on October 20,21 and 23, 2009. Our inspectors documented serious deviations from the Current Good Manufacturing Practice regulation for foods (CGMPs), Title 21, Code of Federal Regulations, Part 110 (21 CFR 110), relating to rice, beans, spices, and other packaged food products, that cause the
products being held and/or repackaged 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)) because they were prepared, packed, or held under insanitary conditions whereby they may have become contaminated with filth, or may have been rendered injurious to health.
In addition, we found that you have serious violations of the seafood Hazard Analysis and Critical Control Point (HACCP) regulation, Part 123 (21 CFR 123). In accordance with 21 CFR 123.6(g), failure of a processor of fish or fishery products to have and implement a HACCP plan that complies with this section or otherwise operate in accordance with the requirements of Part 123 renders the fish or fishery products adulterated within the meaning of Section 402(a)(4) of the Act. Accordingly, your refrigerated anchovies and various squid products are adulterated, in that they have been prepared, packed, or held under insanitary conditions whereby they may have been rendered injurious to health.
Furthermore, as an importer of fish or fishery products, you must operate in accordance with 21 CFR 123.12. In accordance with 21 CFR 123.12(d), there must be evidence that all fish and fishery products offered for entry into the United States have been processed under conditions that comply with 21 CFR 123. If assurances do not exist that the imported fish or fishery product has been processed under conditions that are equivalent to those required of domestic processors under 21 CFR Part 123, the fish or fishery products will appear to be adulterated under Section 402(a)(4) of the Act and will be denied entry. In addition, in accordance with 21 CFR 123.6(g), your imported imitation crab fish cakes are adulterated under Section 402(a)(4) of the Act.
You may find the Act, the CGMPs, the seafood HACCP regulation, and the Fish and Fisheries Products Hazards & Controls Guidance through links in FDA's home page at www.fda.gov.
Your significant violations of the CGMPs were as follows:
1. No pests shall be allowed in any area of a food plant and effective measures must be taken to protect against the contamination of food on the premises by pests, to comply with 21 CFR 110.35(c). However, you failed to exclude insects and rodents from your facility and to protect against the contamination of food on the premises by pests, as evidenced by the following observations of live and dead insects and evidence of rodents throughout the warehouse:
a) On 10/20/09, we observed 34 dead adult moths (approx.1/2") on pallets and near intact sealed boxes of stored food throughout the warehouse;
b) On 10/20/09, we observed one live adult moth (approx. 1/2") and one live fruit fly (approx. 1/4") in-flight, between aisles G and H;
c) On 10/20/09, we observed one live and five dead adult moth (approx. 1/2") three live moth larvae (approx. 1/4"-1/2")and one moth pupa (approx. 1/2") on the outer surface of 3/60 pound bags of unlabeled sea salt stored on the bottom level of the rack on aisle K;
d) On 10/20/09, we observed 13 dead and one live adult moth (approx. 1/2") and one dead moth larva (approx. 1/2/") on the surface of one carton of sesame seeds stored on the bottom level of the rack on aisle J;
e) On 10/20/09, we observed 18 dead adult moths (approx. 1/2/") on the outer surface of 18/10 pound bags of sweet brown rice, stored on the second shelf of the bottom of the rack on aisle M;
f) On 10/20/09, we observed five dead adult moths (approx. 1/2") in clear plastic wrapped around a pallet containing bags of (b)(4) Rice stored on the bottom level of the rack on aisle M. We observed 12 dead adult moths (approx.1/2") within the pallet, on the outer surfaces of these rice bags;
g) On 10/21/09, we observed 18 dead adult moths (approx. 1/2") in clear plastic wrapped around a pallet containing 19/60 bags of (b)(4) rice stored on the bottom level of the rack on aisle M. We observed 31 dead adult moths (approx. 1/2"), one dead adult fly (approx. 1/4"), one dead fruit fly, one dead adult grain beetle (approx. 1/4"), and one live and one dead moth larva (approx. 1/2") on the outer surfaces of these rice bags. We observed 37 dead adult moths (approx. 1/2") on the inside bottom of the pallet, on the cardboard;
h) On 10/21/09, we observed two dead adult moths (approx.1/2") and three moth pupae (approx. 1/2/") in clear plastic wrapped around a pallet containing 4/60 bags of unlabeled soybeans in the repacking room. We observed eight dead adult moths (approx. 1/2") on the outer surfaces of the bagged product;
i) On 10/21/09, we observed one dead adult moth (approx.1/2") and one moth pupa (approx.1/2") in clear plastic wrapped around a pallet containing 16 plastic bags, each containing 6/10 pound paper bags of (b)(4) rice stored on the bottom level of the rack on aisle M. We observed 12 dead adult moths (approx.1/2"), two live and one dead moth larva (each approx.1/2"), two pupa (approx.1/2" and insect frass on the outer surfaces of the bagged product;
j) On 10/21/09, we observed one dead adult moth (approx.1/2"), nine dead moth larvae (approx. 1/2") and four apparent rodent excreta pellets (1/2") on the surface of 25/50 bags of black beans stored on the bottom level of the rack on aisle M;
k) On 10/21/09, we observed five dead adult moths (approx.1/2") inside an opened carton containing bottles of intact teriyaki sauce on aisle M;
l) On 10/21/09 we observed two dead adult moths (approx.1/2") on the surface of a lot of pearl barley (40/50 pound bags) stored on the top level of the rack on aisle M;
m) On 10/21/09, we observed two dead adult moths (approx.1/2") on the surface of a lot of cinnamon (5/50 pound bags) stored on the top level of the rack on aisle M;
n) On 10/20/09, we observed approximately 450 rodent excreta pellets on the floor behind pallets of food stored along the west wall of the ambient warehouse;
0) On 10/20/09, we observed approximately 50 rodent excreta pellets on the floor behind pallets of food stored along the north wall of the ambient warehouse;
p) On 10/20/09, we observed a hole (approx. 6" x 6") in the south wall of the "nonfood" warehouse, approximately 10 rodent excreta pellets and apparent urine stains (3" x 3") in the hole. This hole opened directly to the north wall of the ambient warehouse; and
q) On 10/20/09, we observed approximately 100 rodent excreta pellets on the floor behind pallets of food stored against the west and south walls of the cooler.
2. You must store finished food under conditions that will protect food against physical, chemical, and microbial contamination as well as against deterioration of the food and the container, to comply with 21 CFR 110.93. However, you failed to store finished food under conditions that will protect food against physical, chemical, and microbial contamination as evidenced by the following observations:
a) We observed two plastic gasoline containers holding fuel and six plastic soy sauce containers holding fuel stored within ten feet of cased food.
b) We observed one open box of (b)(4) Joint Compound stored directly within 6" of cased Dried Laver (seaweed).
3. You must provide your plant or facility, where necessary, adequate screening or other protection against pests, to comply with 21 CFR 110.20(b)(7). However, you did not provide adequate screening or other protection against pests as evidenced by gaps (varying in size from 2" - 2') we observed in seven of ten bay doors located on the east wall of your warehouse.
4. You must properly store equipment within the immediate vicinity of the plant buildings or structures that may constitute an attractant, breeding place, or harborage for pests, to comply with 21 CFR 110.20(a)(1). However, you failed to properly store equipment that may constitute an attractant, breeding place, or harborage area for pests as evidenced by our observation of approximately 9000 square feet of space in the north warehouse which contained randomly stored piles of unused food racks, desks, office furniture, lumber, coolers, and miscellaneous items that could serve as a pest harborage area.
Your significant violations of the seafood HACCP regulations were as follows:
1. You must conduct or have conducted for you a hazard analysis for each kind of fish and fishery product that you produce to determine whether there are food safety hazards that are reasonably likely to occur, and you must have and implement a written HACCP plan to control any food safety hazards that are reasonably likely to occur, to comply with 21 CFR 123.6(a) and (b). However, your firm does not have a
HACCP plan for:
a) Refrigerated anchovies, to control the food safety hazards of histamine formation and pathogen growth and toxin formation;
b) Refrigerated vacuum packaged smoked squid, hot roasted squid, and seasoned squid, to control the food safety hazard of Clostridium botulinum growth and toxin production; and
c) Seasoned squid (not vacuum packaged), to control the food safety hazard of pathogen growth and toxin formation.
2. You must implement an affirmative step which ensures that the fish and fishery product(s) you import are processed in accordance with the seafood HACCP regulation, to comply with 21 CFR 123.12(a)(2)(ii). However, your firm did not perform an affirmative step for imitation crab fish cakes manufactured by (b)(4) imported from China.
3. You must maintain sanitation control records that, at a minimum, document monitoring and corrections for the relevant areas of sanitation required to be monitored under the provisions of 21 CFR 123.11(b), to comply with 21 CFR 123.11(c). The relevant areas of sanitation for the storage of your refrigerated seafood products would be likely to include the protection of food, food packaging material, and food contact surfaces from adulteration with lubricants, fuel, pesticides, cleaning compounds, sanitizing agents, condensate, and other chemical, physical,
and biological contaminants; the proper labeling, storage, and use of toxic compounds; and the exclusion of pests from the food plant.
We may take further action if you do not promptly correct these violations. For instance, we may take further action to refuse admission of your imported fish or fishery products under Section 801 (a) of the Act (21 U.S.C. § 381(a)), seize your product(s), and/or enjoin your firm from operating.
You should respond in writing within fifteen (15) working days from your receipt of this letter. Your response should outline the specific things you are doing to correct these violations. You should include in your response documentation such as HACCP and importer verification records and records that document the performance and results of your firm's affirmative steps, or other useful information that would assist us in evaluating your corrections. If you cannot complete all corrections before you respond, you should explain the reason for your delay and state when you will correct any remaining violations.
This letter may not list all the violations at your facility. You are responsible for ensuring that your processing plant operates in compliance with the Act, the CGMPs (21 CFR Part 110) and the seafood HACCP regulation (21 CFR Part 123). You also have a responsibility to use procedures to prevent further violations of the Act and all applicable regulations.
Please send your written reply to the Food and Drug Administration, Attention: Michael J. Donovan, Compliance Officer, 22201 23rd Drive SE, Bothell, WA 98021-4421. If you have any questions regarding this letter, please contact Mr. Donovan at (425) 483-4906.
Sincerely,
/s/
Charles M. Breen
District Director
Enclosure:
Copy of FDA 483
cc: WSDA, with disclosure statement
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